The Aleth Briefs trace each story to its original source and show how the week unfolded.

The week in five lines:

• Moderna’s mRNA delivered landmark phase 3 cancer data, adding $50bn in value.

• Trump nominated White House aide Heidi Overton to run the FDA.

• AstraZeneca won two late-stage lung cancer trials and stopped another.

• argenx’s Vyvgart Hytrulo met its phase 3 myositis endpoint.

• Regeneron won FDA approval for FOP drug Pasatru.

Browse by day:

• Weekend catch-up: Skye-Redx · Lantheus Alzheimer’s · Biogen felzartamab

• Monday: AZ lung trials · argenx · EyePoint · Sandoz-Henlius · Slate-Fulcrum

• Tuesday: Amylyx · LEO-Tanabe · BioMarin-Alesta · Teva · Biokin · China trial deaths

• Wednesday: Moderna-Merck · Regeneron · Ultragenyx · US FDA pick · Aurinia-Teva

• Thursday: UK weekly insulin

Weekend catch-up

Redx Pharma agreed a reverse merger with Nasdaq-listed Skye Bioscience to create Fibrx Therapeutics, backed by $125m of concurrent financing.

The deal finally gives Redx the US public-market listing it has pursued since its failed 2023 reverse with Jounce and 2024 AIM delisting. Fibrx will be built around Redx's fibrosis pipeline and led by its management. The $125m is expected to fund it into 2029 and through phase 2 topline data for lead asset RXC008 in H2 2028.

• Skye Bioscience & Redx Pharma transaction and $125m financings · Skye Bioscience

The FDA approved Lantheus’ tau PET imaging agent for Alzheimer’s disease.

Tauklarify (florquinitau F 18, previously MK-6240) is cleared to image tau neurofibrillary tangle pathology in adults with cognitive impairment being evaluated for Alzheimer’s disease, complementing amyloid PET. The approval comes as Lantheus is being acquired by radiopharma rival Curium in a deal worth up to $8bn.

• FDA approval of TAUKLARIFY Tau PET Imaging Agent for Alzheimer’s · Lantheus

Biogen’s antibody felzartamab won its first approval anywhere, in China.

The anti-CD38 antibody was approved for multiple myeloma, its first authorisation anywhere. More important for Biogen, felzartamab is also in global phase 3 trials in immune-mediated diseases, where the company sees the larger opportunity.

• TJ Biopharma & Biogen first global approval of felzartamab China · TJ Biopharma

Monday 17 August

AstraZeneca won two late-stage lung cancer trials and stopped another.

In DESTINY-Lung04, Enhertu, partnered with Daiichi Sankyo, improved progression-free survival (PFS) over chemotherapy plus Keytruda as first-line treatment of HER2-mutant advanced non-small cell lung cancer. In SAFFRON, Tagrisso plus Orpathys, partnered with HUTCHMED, improved PFS and overall survival in EGFR-mutated disease with high MET overexpression after progression on Tagrisso.

The data extend AstraZeneca’s position in molecularly defined lung cancer, although they came on the same day it discontinued a separate Phase 3 trial of volrustomig.

• Enhertu improved survival 1st-line advanced NSCLC DESTINY-Lung04 · AstraZeneca

• Tagrisso+Orpathys improved survival in EGFR-mutated lung cancer · AstraZeneca

• Update on eVOLVE-Lung02 Phase III of volrustomig in NSCLC · AstraZeneca

argenx’s Vyvgart Hytrulo met its phase 3 endpoint in myositis.

In the ALKIVIA trial, Vyvgart Hytrulo (efgartigimod) delivered a 15.4-point greater improvement in mean Total Improvement Score at week 52 than placebo (p=0.0011) across the combined immune-mediated necrotising myopathy and dermatomyositis population, with benefit from week 4. It is the first phase 3 trial to show a benefit in immune-mediated necrotising myopathy, which has no approved therapy.

• Positive Topline Results Phase 3 ALKIVIA efgartigimod autoimmune myositis · argenx

EyePoint’s Duravyu missed its primary endpoint in wet AMD.

In LUGANO, the first of two phase 3 trials, Duravyu (vorolanib) failed to meet its prespecified non-inferiority endpoint against Eylea on mean change in best corrected visual acuity. EyePoint said the result was affected by nine patients, about 4% of the cohort, with vision loss it considered unrelated to wet AMD. An ad hoc analysis excluding those patients met the non-inferiority threshold. The company still plans to file in H1 2027, subject to results from the identical LUCIA trial due in Q4 2026.

• Topline Data LUGANO, first of two Phase 3 trials DURAVYU Wet AMD · EyePoint

Sandoz agreed to pay up to $322m for three Henlius biosimilars.

Shanghai Henlius granted Sandoz exclusive registration and commercialisation rights outside China to as many as 10 proposed antibody and antibody-drug conjugate biosimilars, with proposed cetuximab, evolocumab and belimumab copies first. Sandoz pays up to $322m in total, of which up to $100.5m is invoiced in 2026.

• Sandoz strategic collaboration unlock value of biosimilars Platform · Henlius

Slate agreed a merger with Fulcrum Therapeutics and $245m in commitments.

The all-stock merger would take migraine developer Slate onto Nasdaq, alongside a committed $245m private placement led by Frazier Life Sciences. The combined company will retain the Slate name. Lead asset SLTE-1009 is a subcutaneous anti-PACAP/VIP antibody, and the financing is expected to fund operations into 2029.

• Fulcrum Therapeutics and Slate Medicines announce merger agreement · Fulcrum

Tuesday 18 August

Amylyx’s GLP-1 antagonist avexitide cut hypoglycaemic events by more than half in phase 3.

In the LUCIDITY trial in 78 patients with post-bariatric hypoglycaemia after gastric bypass, avexitide reduced the composite rate of Level 2 and Level 3 hypoglycaemic events by 55% versus placebo (p=0.000003) and met every secondary endpoint. Amylyx plans to file by year-end for a condition with no approved treatment.

• Positive topline Phase 3 LUCIDITY Avexitide Post-Bariatric Hypoglycemia · Amylyx

LEO Pharma agreed to acquire worldwide rights to dersimelagon from Tanabe Pharma for up to $435m.

Dersimelagon is an oral MC1R agonist for erythropoietic protoporphyria and X-linked protoporphyria. It has completed phase 3, is filed and awaits an FDA decision. The deal gives LEO a late-stage rare-disease asset close to potential launch in dermatology.

• LEO Pharma strengthens late-stage pipeline acquisition dersimelagon · LEO Pharma

BioMarin agreed to buy Alesta Therapeutics for $275m upfront.

The deal brings ALE1, an oral small molecule that could become the first oral therapy for hypophosphatasia, a rare bone disease. Alesta will spin out its other assets before closing, expected this quarter. ALE1 adds to BioMarin’s skeletal conditions portfolio.

• Acquiring Alesta Therapeutics ALE1, potential first oral Hypophosphatasia · BioMarin

A federal appeals court handed Teva a partial win against Medicare price negotiations.

The US Court of Appeals for the D.C. Circuit sent back to a lower court the question of whether CMS's “bona fide marketing” standard, which determines when a drug becomes eligible for negotiation, complies with the Inflation Reduction Act. The court did not rule that the standard itself was unlawful. Teva's broader constitutional challenges were unsuccessful.

• Teva Pharmaceuticals v. Kennedy, No. 25-5425, opinion · US Court of Appeals

• Teva scores rare partial win in CMS price negotiation appeal · Fierce Pharma

Biokin’s iza-bren, partnered with BMS, met its phase 3 endpoint in lung cancer.

In the China BL-B01D1-301 trial, the EGFR×HER3 bispecific ADC met its primary progression-free survival endpoint at an interim analysis in EGFR-mutated non-small cell lung cancer after EGFR-TKI treatment, with a positive trend in overall survival. It is the fourth phase 3 study in which iza-bren has met its primary endpoint.

• Meeting primary endpoint interim analysis phase III iza-bren NSCLC · SINA

• Biokin, BMS’ bispecific ADC hits goal in China lung cancer trial · Fierce Pharma

A third patient death was reported in China's investigator-initiated cell and gene therapy trials.

Endpoints reported a previously undisclosed death in a CAR-T study, following two recently reported deaths in experimental gene-therapy trials. The cases have increased scrutiny of transparency and oversight in China’s investigator-initiated trial (IIT) system.

• Third death revealed in China’s popular but opaque trials · Endpoints News

• After 2 deaths, can China’s alternative regulatory path be trusted? · Fierce Biotech

Wednesday 19 August

Moderna’s mRNA cancer therapy met two phase 3 endpoints in melanoma.

In INTerpath-001, intismeran autogene, Moderna’s personalised mRNA neoantigen therapy, plus Merck’s Keytruda beat Keytruda alone on recurrence-free survival and distant metastasis-free survival at a prespecified interim analysis in patients with completely resected stage IIB-IV melanoma. The trial continues to evaluate other secondary endpoints, including overall survival.

It is the first positive phase 3 trial of an individualised neoantigen therapy and the first for an mRNA cancer therapy. The result validates a personalised treatment model in which tumour sequencing, computational neoantigen selection and patient-specific mRNA manufacturing are combined to generate anti-tumour T-cell responses in vivo. Moderna shares rose 177%, adding about $45bn to its market value, reflecting the broader potential of the platform beyond melanoma.

• Merck and Moderna Announce Phase 3 INTerpath-001 Trial of Intismeran Autogene Plus KEYTRUDA Met Endpoints of RFS and DMFS in Melanoma · Moderna

Regeneron won FDA approval for FOP drug Pasatru.

Pasatru, an antibody targeting Activin A, was approved to reduce new heterotopic ossification lesions and clinician-assessed flare-ups in adults with fibrodysplasia ossificans progressiva, the ultra-rare disease in which soft tissue turns to bone. In the phase 3 trial, two doses reduced new lesions by 90% and 94% vs placebo at 56 weeks.

• Pasatru first only FDA-approved heterotopic ossification lesions FOP · Regeneron

Ultragenyx won its first gene therapy approval, in a rare metabolic disease.

The FDA granted accelerated approval to Genglycos for patients eight and older with glycogen storage disease type Ia. Genglycos is designed to address enzyme deficiency and reduce dependence on cornstarch used to maintain blood glucose. It is Ultragenyx’s first marketed gene therapy, and came with a Priority Review Voucher.

• Ultragenyx announces U.S. FDA approval of GENGLYCOS gene therapy · Ultragenyx

Trump picked Heidi Overton to run the FDA.

The president nominated White House policy aide Heidi Overton, M.D., Ph.D., as FDA commissioner. She faces Senate confirmation and would take over an agency that has lost around one in six of its staff over the past year (>3,000), after months of leadership turnover and regulatory controversy. Reuters reported concern among drugmakers and FDA staff over her limited management experience.

• Trump selects Heidi Overton as FDA commissioner · Truth Social

• Trump picks White House ally Overton to lead embattled FDA · Reuters

The FDA cleared the first standalone robotic blood-draw device.

The FDA authorised Vitestro's Aletta through the De Novo pathway, the first standalone robotic device able to draw blood from a patient's arm without hands-on intervention. It uses near-infrared imaging and ultrasound to locate a vein and automates the draw. A phlebotomist supervises up to three devices, with sensors that stop or pause the procedure if the patient moves or another safety issue is detected. FDA said success rates were comparable with or better than trained phlebotomists.

• FDA Authorizes First-of-Its-Kind Robotic Blood Draw Device · FDA

A US appeals court sided with Parse Biosciences over 10x Genomics on patents.

The Federal Circuit upheld the Patent Trial and Appeal Board's invalidation of three 10x Genomics patents in its dispute with Qiagen-owned Parse Biosciences. The ruling removes three patents from 10x's enforcement arsenal in the single-cell sequencing market, where the two companies compete directly.

• 25-1199: 10X Genomics, Inc. v. Parse Biosciences, Inc. [Opinion], Nonprecedential · US Court of Appeals for the Federal Circuit

Aurinia settled with Teva over Lupkynis generic entry in December 2036.

The settlement allows Teva to launch its generic version of Lupkynis (voclosporin) in the US no earlier than 7 December 2036, subject to defined contingencies and FDA approval. Teva also acknowledged two Aurinia patents as valid, enforceable and infringed by its proposed product. Aurinia continues to litigate separate generic challenges from other companies, so the agreement does not resolve all generic risk.

• Aurinia Settles Patent Litigation with Teva · Aurinia Pharmaceuticals

• Aurinia deal with Teva keeps Lupkynis generic in check until ‘36 · Fierce Pharma

Thursday 20 August

NICE backed Lilly’s weekly insulin Onswik for the NHS.

The cost watchdog recommended insulin efsitora alfa, also known as Onswik, for type 2 diabetes in final draft guidance. It controls blood glucose as well as widely used long-acting insulins while cutting injections by 85%, from daily to once a week. NICE said it could particularly benefit people who rely on a carer or nurse for injections. The recommendation remains subject to MHRA licensing before NHS use.

• Weekly insulin jab could cut injections from 365 a year to just 52 · NICE

ALETH · OPEN ACCESS RESEARCH

aleth.co

The Aleth Briefs trace each story to its original source and show how the week unfolded.

The week in five lines:

• The White House ordered an overhaul of US childhood vaccination schedules.

• The FDA proposed 50% fee cuts for US-run trials.

• Jazz and Actio agreed a $1.3bn rare-epilepsy deal.

• Sionna dropped SION-719 after a phase 2 miss.

• Definium’s LSD pill cleared a second phase 3.

Browse by day:

• Weekend catch-up: WuXi ruling

• Monday: US vaccines · Jazz-Actio · Sionna · UK Foundayo · MoonLake · Sobi-Innate

• Tuesday: Autolus · Vaderis · Vykat XR

• Wednesday: Definium · Cullinan-Taiho · MMR pushback · Sangamo auction

• Thursday: US user fees · Tavneos

Weekend catch-up

A US federal judge blocked the Pentagon from enforcing WuXi AppTec’s designation as a Chinese military company.

A US District Court granted a preliminary injunction barring the Department of Defense from effecting the Section 1260H listing while WuXi’s challenge runs, finding the company likely to show the designation was arbitrary and capricious. WuXi had documented clients cancelling and moving work to rivals since the June listing.

• WuXi AppTec Co., Ltd. v. US Department of Defense, 1:26-cv-02069 · CourtListener

• Judge blocks listing of WuXi AppTec as ‘Chinese military’ · Pharma Manufacturing

Monday 10 August

The White House ordered a rewrite of US childhood vaccine schedules.

The executive order, “Delivering Gold Standard Childhood Vaccine Recommendations for Americans”, cuts the universally recommended childhood vaccinations from 17 to 11, moves shots including hepatitis B, rotavirus, influenza and COVID-19 to high-risk or shared decision-making categories, and directs that the MMR vaccine be given as three separate shots once single-disease versions exist in the US.

• Gold standard childhood vaccine recommendations for Americans · White House

Jazz agreed to buy Actio Biosciences for up to $1.32bn.

Jazz Pharmaceuticals will pay $820m upfront and up to $500m in contingent consideration for the private biotech, whose lead asset ABS-1230 is a potential first-in-class KCNT1 ion channel inhibitor for a rare genetic epilepsy affecting 2,500 in the US. The deal extends the epilepsy business built on Epidiolex (cannabidiol, GW Pharma).

• Acquiring Actio Biosciences, expanding rare epilepsy portfolio · Jazz Pharmaceuticals

Sionna’s cystic fibrosis add-on failed.

In the phase 2a PreciSION CF trial, SION-719 added to Trikafta shifted sweat chloride by a placebo-adjusted -1.0 mmol/L (p=0.7). Sionna Therapeutics will not take the NBD1 stabiliser forward as an add-on to standard of care. Sionna named SION-451 plus SION-2222 as its preferred pairing while it weighs next steps.

• Topline data from two development programs in CF · Sionna Therapeutics

The MHRA authorised Lilly’s orforglipron, the first regulator in Europe to clear it.

Foundayo (orforglipron) is authorised for weight loss in adults with obesity or overweight plus a comorbidity, and separately for inadequately controlled type 2 diabetes. It is the second oral GLP-1 cleared for weight loss in the UK in two months, after Novo Nordisk’s oral Wegovy in June. NHS use will require NICE evaluation first.

• UK first in Europe to authorise orforglipron for weight loss and diabetes · MHRA

MoonLake’s sonelokimab met its endpoints in first phase 3 in psoriatic arthritis.

In IZAR-1, 42.1% of biologic-naive patients on the nanobody’s 60 mg induction regimen reached ACR50, with wins across key secondary endpoints and no new safety signals. The trial runs to week 52, reading out fully in H1 2027; IZAR-2, in TNF-inadequate responders with a Skyrizi reference arm, completes enrolment in Q3 2026.

• Positive topline results phase 3 of sonelokimab · MoonLake Immunotherapeutics

Sobi licensed Innate Pharma’s lacutamab in a deal worth up to $580m.

Sobi pays $75m at closing for global rights to commercialise the anti-KIR3DL2 antibody on any accelerated approval in Sézary syndrome, with up to $40m in near-term milestones and up to $465m tied to an option over full development rights.

• Partnership with Innate Pharma to license lacutamab in T-cell lymphoma · Sobi

The FDA rejected ITM’s radiopharmaceutical over manufacturing issues.

The complete response letter for 177Lu-edotreotide (ITM-11) in gastroenteropancreatic neuroendocrine tumours rests on chemistry, manufacturing and controls (CMC) deficiencies and unresolved conditions at a third-party facility. It raised no clinical or safety concerns and asks for no new trials. The phase 3 COMPETE trial had beaten everolimus on progression-free survival. ITM intends to resubmit.

• ITM Receives Complete Response Letter for 177Lu-edotreotide (ITM-11) · ITM

Revolution Medicines and BeOne Medicines agreed a RAS collaboration.

BeOne takes exclusive rights to Revolution’s four clinical RAS(ON) inhibitors in selected Asian markets ex-Japan and South Korea and will fund a global registrational phase 3. The pair will also test combinations pairing daraxonrasib and zoldonrasib with BeOne’s PRMT5 inhibitor and its EGFR x MET x MET trispecific antibody.

• BeOne clinical and regional commercialization collaboration · Revolution Medicines

Silence Therapeutics’ divesiran hit in phase 2 and it priced a $175m offering.

In the 48-patient SANRECO polycythaemia vera trial, 88% on the siRNA responded against 19% on placebo, while phlebotomies fell to 0.2 against 2.1 (per pt, p<0.0001). Phase 3 starts H1’27. Silence priced an upsized $175m offering at $13.50 the next day.

• Positive topline results for divesiran & $175m offering · Silence · Silence

AbCellera’s mAb cut hot flushes 83% in phase 2 and it priced a $200m offering.

A single 600 mg dose of ABCL635 cut daily moderate-to-severe hot flushes by 83% reduction against 33% placebo, with no serious adverse events among 92 postmenopausal women. AbCellera priced an oversubscribed $200m offering at $9.75.

• Positive topline results for ABCL635 & $200m offering · AbCellera · AbCellera

Quanterix cut its 2026 revenue guidance by 15% and its shares fell about 40%.

Q2 revenue of $32.9m came in 9% below the company’s own May guidance, with pro forma revenue down 23% YoY, and the full-year range falls to $142m-$148m from $169m-$174m on weak academic and government demand and execution challenges.

• Quanterix releases financial results for the second quarter of 2026 · Quanterix

Tuesday 11 August

Autolus confirmed Q2 Aucatzyl revenue of $45.7m, up 119% YoY.

Q2 net revenue for Aucatzyl reached $45.7m, up 119% YoY, taking H1 to $71.9m; the London-based company guides 2026 sales of $140-$150m. Enrolment continues in lupus nephritis, paediatric acute lymphoblastic leukaemia and multiple sclerosis.

• Second quarter 2026 financial results and business updates · Autolus Therapeutics

Vaderis raised a $152m series B and started a phase 3 in a rare vascular disorder.

The Swiss biotech’s engasertib, an oral allosteric AKT inhibitor, enters the global phase 3 HEROIC study in hereditary haemorrhagic telangiectasia, which has no approved treatment anywhere. Goldman Sachs Alternatives and TCGX co-led the round.

• Oversubscribed $152m Series B financing & Phase 3 study · Vaderis Therapeutics

Prader-Willi organisations flagged serious adverse events reported on Neurocrine’s Vykat XR.

A joint statement from PWSA USA, the Foundation for Prader-Willi Research and IPWSO urges careful patient selection and monitoring after post-marketing reports of oedema, respiratory and cardiac complications. Fierce Pharma reported seven deaths and >100 serious adverse events in the FDA’s adverse event system. Neurocrine, which took on Vykat XR (diazoxide choline) in its $2.9bn Soleno purchase, says the drug has “a compelling risk-benefit profile in the context of a very serious disease.”

• PWS organizations share joint statement on VYKAT XR adverse events · PWSA USA

• Neurocrine stands by blockbuster hopeful as docs raise safety flags · Fierce Pharma

Wednesday 12 August

Definium’s LSD pill cleared its second phase 3.

In the Voyage trial in generalised anxiety disorder, DT120 (lysergide) 100 µg cut the Hamilton Anxiety score by 11.6 points against 6.2 on placebo at week 12 (p<0.0001). It is the second positive phase 3 for the orally disintegrating tablet after June’s Emerge readout in major depression. The FDA has granted breakthrough therapy designation in anxiety. A second trial, Panorama, reads out in September.

• Topline results from Phase 3 Voyage study of DT120 ODT · Definium Therapeutics

Taiho and Cullinan’s zipalertinib met its phase 3 goal in first-line lung cancer.

In a planned interim analysis of the 285-patient REZILIENT3 trial, the EGFR inhibitor plus chemotherapy improved progression-free survival in untreated EGFR exon 20 insertion non-small cell lung cancer. Pending FDA discussions, the partners plan to pursue US approval, which would take the drug into Rybrevant’s (J&J) territory.

• Zipalertinib meets primary endpoint of PFS in Phase 3 REZILIENT3 · Taiho Oncology

Merck and GSK pushed back on splitting the MMR vaccine.

Both makers of the US combination shot told Reuters there is no published evidence to support separating it, and neither set out plans to. Merck said single-disease approvals could take “as many as 10“ years. No standalone measles, mumps or rubella shot has been sold in the US since Merck stopped making them in 2008.

• Goal to split MMR vaccine could take a decade, experts say · Reuters via KFGO

Sangamo selected PTC and Lilly as winning bankruptcy-auction bidders.

PTC bid $111m at closing plus up to $100m in approval milestones for the Fabry disease gene therapy isaralgagene civaparvovec. Lilly takes the capsid, zinc finger and MINT platforms and the prion disease programme for $50m. Winning bids total $163.6m in cash, subject to approval by the US Bankruptcy Court (Delaware) in Q3.

• Sangamo selects successful bidders following asset auction · Sangamo Therapeutics

Thursday 13 August

The FDA proposed a 50% fee cut for US-based phase 1 trials.

The proposed PDUFA VIII commitment letter, covering fiscal years 2028 to 2032, would halve the application fee where a filing includes clinical data from at least one phase 1 trial run in the US and begun after 1 October 2027.

• PDUFA VIII: Fiscal Years 2028-2032 · FDA

EMA says Tavneos approval relied on “incorrect and misleading” trial data.

The CHMP recommended revoking Tavneos (avacopan) in June, with the European Commission making that decision legally binding across the EU on 4 August. The EMA has now published the grounds for that decision, concluding that the ADVOCATE trial supporting approval breached good clinical practice and that its data could no longer be relied on to demonstrate effectiveness. CSL’s Vifor unit is managing the withdrawal.

• Tavneos: Article 20 referral · European Medicines Agency

• EC adopts decision to revoke marketing authorisation for TAVNEOS (avacopan) · CSL

ALETH · OPEN ACCESS RESEARCH

aleth.co

The Aleth Briefs trace each story to its original source and show how the week unfolded.

The week in five lines:

• AstraZeneca and Bristol Myers Squibb merger talks were reported, then denied.

• Curium and Lantheus agreed an $8bn radiopharma deal.

• Supernus and Indivior agreed a $7.5bn all-stock merger

• Moderna secured approval for the first mRNA flu vaccine.

• Latigo and BlossomHill closed a four-IPO week in the US.

Browse by day:

• Monday: Curium-Lantheus · Supernus-Indivior · KKR-Integer · BioNTech · Gilead

• Tuesday: Pfizer · Novo Nordisk · Merck TL1A · Pathos AI · P&G-Thorne

• Wednesday: Takeda US approval · Eli Lilly · Attovia · PacBio · GRAIL · LifeMine

• Thursday: Replimune · Moderna · Tarsus-Alkeus · Braveheart · Intellia · FDA pilot · AI

• Friday: Latigo · BlossomHill

Story of the week

The FT reported that AstraZeneca and BMS had held talks about a $400bn merger which if true would create the world’s fourth-largest drugmaker by value

The weekend report triggered sharp market reactions on Monday, despite neither company issuing official comment. AZ shares fell as much as 9% in early trading, its worst move since 2020, while BMS gained 6% in US pre-market trading.

In a Reuters article on Wednesday, an insider dismissed the speculation entirely. “There is no deal between AstraZeneca and BMS. There never was a deal to be done, and there are no discussions between the companies,” the source stated.

• AstraZeneca holds talks with BMS over $400bn tie-up · Financial Times

• Exclusive: ‘No discussions’ over AstraZeneca-BMS deal, senior source says · Reuters

Weekend catch-up

Monday 3 August

Curium agreed to buy Lantheus in a deal worth up to $8bn.

Curium, which is PE backed, will pay $102.50/share in cash plus contingent value rights (CVRs) worth up to $12.00/share on commercial milestones to 2030. The CVRs split $6.00 to prostate cancer diagnostics, $3.00 neurology and $1.00 the DEFINITY imaging agent. The combination would put diagnostic and therapeutic radioligand assets under one owner across more than 70 countries. Expects to close H1 2027.

Curium Announces Definitive Agreement to Merge with Lantheus · Curium

Supernus and Indivior agreed an all-stock merger to create a $7.5bn in value and $2.2bn in revenue central nervous system drugmaker.

Each Supernus share converts into 1.54 Indivior shares, leaving Indivior holders with about 56.5% and Supernus holders 43.5%. Indivior shareholders also take a $1bn special cash dividend before closing, funded partly by a $650m Citibank term loan. The combined company keeps the Supernus name and Jack Khattar as CEO. It targets $888m of adjusted EBITDA including $125m cost synergies. Expects to close Q4 2026.

• Supernus and Indivior to Merge · Supernus Pharmaceuticals

KKR is taking US device maker Integer private at an enterprise value of $5.7bn.

Integer shareholders get $127.00/share in cash, 51.8% above the 29 April close, the day before it announced a strategic review, and 28.8% above the 30-day volume-weighted price to 31 July. There is no financing condition. Expects to close end 2026

Integer to Be Acquired by KKR in Transaction Valued at $5.7 Billion · Integer Holdings

BioNTech named Sobi chief executive Guido Oelkers as its next chief executive.

Oelkers takes office by 1 February 2027 and succeeds co-founder Ugur Sahin, who leaves with CMO Ozlem Tureci to run a new next-gen mRNA company. Oelkers more than quadrupled revenue at Sobi over 2017 to 2026. He will prioritise BioNTech’s evolution into a global biopharma firm with multiple approved products by 2030.

• Appointment of Guido Oelkers to Board as Chief Executive Officer · BioNTech

The Supreme Court of California ruled that drugmakers owe no duty to bring a safer alternative to market sooner, ending class action litigation against Gilead.

Justice Groban wrote manufacturers “do not owe a duty of care to users of a nondefective drug when making decisions about whether and when to commercialize an allegedly safer alternative.” The plaintiffs took Viread and argued Gilead had held back Vemlidy to protect revenue. It reverses and earlier Court of Appeal decision.

• Gilead Tenofovir Cases, S283862 · Supreme Court of California

Tuesday 4 August

Pfizer added $2.5bn to its cost-cutting programme.

The new reductions run from 2027 to 2029 and take targeted net savings to $9.7bn through 2029. Q2 revenue was $15.0bn, up 1%, with adjusted earnings of $0.77 a share. Pfizer lifted its 2026 revenue guidance by $500m to $60.5-$62.5bn.

Pfizer Reports Q2 Results And Raises Midpoint of 2026 Revenue Guidance · Pfizer

Novo Nordisk raised its 2026 guidance driven by GLP-1 volumes.

Adjusted sales grew 7% at CER to DKK 78.5bn and adjusted operating profit 11% to DKK 33.4bn. Full-year adjusted sales and operating profit growth is now guided at 0% to -6%, against -4% to -12% before. The Wegovy pill has passed 5m prescriptions since launch and was running above 265,000 a week in mid-July.

• Novo Nordisk reports Q2 2026 and raises full-year outlook · Novo Nordisk

Merck’s anti-TL1A antibody tulisokibart met its endpoints in hidradenitis suppurativa and missed in a rare lung disease.

The systemic sclerosis-associated interstitial lung disease programme is discontinued, and the full hidradenitis results go to a medical meeting. Merck paid $10.8bn for Prometheus Biosciences to acquire the antibody. Q2 sales were $16.6bn, up 5%, with $8.4bn from Keytruda and a $2.31/share charge tied to the Terns Pharma purchase.

Q2 2026 Financial Results; Key Regulatory & Clinical Milestones · Merck & Co

Pathos AI licensed Alphamab Oncology’s TROP2/HER3 bispecific antibody-drug conjugate in a deal worth up to $2.2bn.

Pathos pays $125m upfront for rights outside mainland China, Hong Kong, Macau and Taiwan, with up to $2.09bn in milestones and tiered royalties. JSKN016 is already in phase 3 in triple-negative breast cancer in China. Pathos also named AZD4241, an oestrogen-receptor PROTAC licensed from AstraZeneca, in its pipeline.

• Global Licensing Agreement with Alphamab Oncology on JSKN016 · Pathos AI

P&G agreed to buy US supplements maker Thorne from L Catterton for $3.8bn.

L Catterton bought into the vitamins, minerals and supplements firm in October 2023.

Sale of Thorne to The Procter & Gamble Company for $3.8 Billion · L Catterton

Wednesday 5 August

Takeda won US approval for the first orexin agonist for narcolepsy.

The FDA cleared Orzeyful, an oral orexin receptor 2 agonist, for narcolepsy type 1 in adults. It is the first disease modifying medicine directed at orexin deficiency and improved excessive daytime sleepiness, cataplexy and quality of life in phase 3 trials.

• FDA Approves ORZEYFUL for Adults With Narcolepsy Type 1 · Takeda

Eli Lilly raised guidance as tirzepatide neared two-thirds of revenue.

Q2 revenue was $23.0bn, up 48%: Mounjaro (tirzepatide for type 2 diabetes) took $9.9bn, up 91%, and Zepbound (for weight loss) $4.9bn, up 46%. The newly launched oral GLP-1 Foundayo (orforglipron) took $98m. Lilly raised 2026 revenue guidance +3% to $85-$87bn from $82-$85bn and narrowed EPS guidance to $35.50-$36.50.

• Lilly reports second-quarter 2026 financial results, raises full-year guidance · Eli Lilly

Attovia Therapeutics priced an upsized $289m Nasdaq IPO.

The company sold 17m shares at $17.00 and began trading as ATTO. Proceeds fund three immunology candidates, led by the anti-IL-31 antibody ATTO-1310 in chronic itch, which is positioned against Sanofi and Regeneron’s Dupixent (dupilumab).

• Pricing of Upsized Initial Public Offering · Attovia Therapeutics

PacBio replaced its chief executive, cut its revenue guidance and restructured.

COO Mark Van Oene became president and CEO with immediate effect, succeeding Christian Henry after six years; Henry stays on the board and will advise to end 2026. 2026 revenue guidance fell $10m (6%) to $155-$165m. Q2 revenue was $39.0m vs $39.8m, the net loss widened to $44.7m, and cash fell to $236.9m from $314.7m.

• PacBio Second Quarter 2026 Financial Results · Pacific Biosciences

• PacBio Appoints Mark Van Oene as President and CEO · Pacific Biosciences

GRAIL expects an FDA advisory committee this autumn on Galleri, its multi-cancer early detection (MCED) blood test.

The premarket approval application rests on 25,000 PATHFINDER 2 participants with a year of follow-up and on the first screening round of the 140,000-participant NHS-Galleri trial in England. Q2 revenue rose 26% to $44.7m and Galleri volume 35% to >61,000 tests, against a net loss of $110.2m and cash of $861.6m. GRAIL also closed a $110m equity financing with Samsung to sell Galleri in South Korea.

• GRAIL Reports Second Quarter 2026 Financial Results · GRAIL

LifeMine raised a $188m series E to take transplant drug into later trials.

A $75m series D from Q4 2025 and an oversubscribed $188m series E led by Milky Way Investments, with Bezos Expeditions, Gates Frontier, RA Capital, GV and ARCH Venture Partners, fund LIFE-001. The molecule came out of mining fungal genomes, is given as a long-acting injection and does not enter the brain.

• $263m raise to Accelerate Clinical Development of LIFE-001 · LifeMine Therapeutics

Thursday 6 August

Stanford and Arc Institute scientists designed 16 viable bacteriophages with AI.

Writing in Science, the team used the Evo genome language model to generate whole bacteriophage genomes letter by letter, synthesised hundreds of candidates and found 16 that were viable. All 16 infect E. coli and pose no threat to humans. A cocktail of them overcame bacteria that had resisted a natural phage. The research highlights the need for biosecurity governance guardrails to be properly established.

• Generative design of bacteriophages with genome language models · Science

FDA approved Replimune’s Tudriqev for advanced melanoma at the 3rd attempt.

The accelerated approval covers Tudriqev with Opdivo in unresectable advanced cutaneous melanoma that has progressed on an anti-PD-1 regimen. About a quarter of evaluable patients in the single-arm trial responded, for a median of just over 14 months. Continued approval depends on the confirmatory phase 3 IGNYTE-3 trial.

• FDA Accelerated Approval of TUDRIQEV with Nivolumab · Replimune

Moderna won US approval for the first mRNA flu vaccine.

mFLUSIVA (mRNA-1010) is cleared for adults 50 and over: a standard approval for those 50-64 based on a 40,805-participant phase 3 in 11 countries, and accelerated approval for those 65 and over based on immunogenicity data from 2,992 US adults, with a confirmatory study required. This reverses a refusal to file the agency issued on the same application earlier this year. Supply is expected for the 2026-27 season.

• Moderna Receives U.S. FDA Approval for Influenza Vaccine mFLUSIVA · Moderna

Tarsus Pharmaceuticals agreed to buy Alkeus Pharmaceuticals for $450m up front, taking it into inherited retinal disease.

Tarsus pays $270m in cash and $180m in stock, with up to $350m on regulatory approval and first commercial sale plus tiered royalties. Alkeus’s gildeuretinol is in the 230-patient phase 3 NORTHSTAR trial in Stargardt disease, which affects >36,000 Americans and has no approved treatment; topline data are due in H2 2029.

Tarsus to Acquire Alkeus and Advance Eye Care Leadership · Tarsus Pharmaceuticals

Braveheart Bio priced an upsized $382.5m IPO above its range.

The company sold 21.25m shares at $18.00, against a marketed $15 to $17, and began trading as BRVE. Proceeds fund phase 3 work on a cardiac myosin inhibitor licensed from Jiangsu Hengrui for hypertrophic cardiomyopathy, against BMS’s Camzyos.

• Braveheart Bio Announces Pricing of Upsized Initial Public Offering · Braveheart Bio

Intellia linked the liver enzyme spikes in its CRISPR trials to a single HLA allele.

A genomic analysis of >600 patient samples across the nex-z programme found the highest transaminase elevations in carriers of one HLA allele. Intellia is discussing the finding with regulators and will screen patients entering its phase 3 trials.

• Intellia Announces Q2 2026 Results and Business Updates · Intellia Therapeutics

The FDA set out how its proposed expedited investigational new drug (IND) pilot would work.

Qualified research institutions, CROs and other third parties would help sponsors prepare and pre-review IND material on a rolling basis, shortening the time from picking a molecule to a first-in-human trial. The FDA would keep full authority over regulatory decisions, including the power to place a trial on clinical hold.

• Expedited IND Pilot Program Educational Webinar for Stakeholders · FDA

• Expedited IND Pilot Program; Request for Information · Federal Register

Friday 7 August

Latigo and BlossomHill priced IPOs to close four biotech IPOs this week.

Latigo Biotherapeutics sold 19.2m shares at $18.00 for $345.6m, funding LTG-001, an oral NaV1.8 painkiller positioned against Vertex Pharmaceuticals’ Journavx.

BlossomHill Therapeutics sold 9.375m shares at $16.00 for $150m, funding: BH-30643 in EGFR-mutant lung cancer, a would-be rival to AstraZeneca’s Tagrisso; and BH-30236 in acute myeloid leukaemia and higher-risk myelodysplastic syndrome.

Both begin trading today, taking the week’s US biotech IPOs to four and $1.2bn raised.

• Latigo Announces Pricing of Upsized $345.6m IPO · Latigo Biotherapeutics

• BlossomHill Announces Pricing of Upsized $150m IPO · BlossomHill Therapeutics

ALETH · OPEN ACCESS RESEARCH

aleth.co

The Aleth Briefs trace each story to its original source and show how the week unfolded.

The week in five lines

• Biopharma dealmaking hit a record $170bn in H1 2026.

• GSK chose Cambridge for its new R&D HQ.

• Novo Nordisk‘s ziltivekimab failed its heart trial.

• Johnson & Johnson offered $5.5bn to settle talc claims.

• argenx agreed to buy Forte Biosciences for $2.2bn.

In this edition

• Monday: argenx-Forte deal; AstraZeneca Q2; Otsuka ADHD approval; Freenome-Abbott test; J&J talc settlement

• Tuesday: GSK move to Cambridge; US Medicare Part D

• Wednesday: UK social care; FTC v Hims; J&J-Sail CAR-T; Biogen Leqembi; Capricor DMD vote; Latigo pain; record biopharma M&A

• Thursday: Sanofi cleanup; Replimune adcomm; Alnylam cut; US pharma tariffs; decongestant suit; Illumina guidance; biotech IPOs

• Friday: Novo ZEUS failure; Datroway EU approval

Monday 27 July

argenx agreed to buy Forte Biosciences for $2.2bn, gaining a first-in-class antibody in vitiligo and coeliac disease.

The Dutch-Belgian immunology group is paying $77 a share in cash, an 86% premium to Forte’s volume-weighted price since it reported positive phase 1b vitiligo data on 9 July. It gains FB102, an anti-CD122 antibody with early proof-of-concept in vitiligo and coeliac disease, with phase 2 readouts due in H2 2026. The deal carries argenx beyond the neuromuscular and autoantibody diseases it built Vyvgart (efgartigimod) around, into two indications with no established drug.

• argenx to Acquire Forte Biosciences, Adding First-in-Class anti-CD122 FB102

AstraZeneca posted an overall-survival win for its Claudin 18.2 drug in gastric cancer and a rare-disease miss for Ultomiris, alongside Q2 results.

AZ said sonesitatug vedotin met the overall-survival primary endpoint in later-line CLDN18.2-positive advanced gastric cancer and a key secondary endpoint in the broader population, although PFS missed significance. Ultomiris failed on event-free survival in transplant-associated thrombotic microangiopathy. Management retained its $80bn 2030 revenue target.

• Half-year Financial Report - AstraZeneca (RNS)

• Update on Phase III trial of Ultomiris in adults and adolescents with thrombotic microangiopathy after haematopoietic stem cell transplant - AstraZeneca

The FDA approved Otsuka’s Simtriyo (centanafadine), the first triple reuptake inhibitor for ADHD.

Otsuka announced the approval on 27 July for adults and children aged six and over, three days after the agency cleared it. Simtriyo blocks reuptake of norepinephrine, dopamine and serotonin, a mechanism no approved ADHD drug uses, and must clear controlled-substance scheduling before it can launch.

• Otsuka Receives FDA Approval for First-in-Class SIMTRIYO for Treatment of ADHD

The FDA approved Freenome’s SimpleScreen blood test for colorectal cancer, with Abbott to sell it in the US.

The approval turns SimpleScreen from a lab service into a product Freenome can sell. Under a 2025 agreement, Abbott’s diagnostics operation will commercialise SimpleScreen from this autumn, triggering a $100m milestone for Freenome. In the >48,000-patient PREEMPT CRC study, the test detected colorectal cancer with 81% sensitivity and showed 90% specificity for advanced neoplasia. The test offers a blood-draw alternative to colonoscopy and stool testing, which many patients avoid.

FDA Approves Freenome’s SimpleScreen CRC Blood-Based Screening Test; Abbott to Commercialize in the U.S.

Johnson & Johnson offered $5.5bn to settle ovarian-cancer talc litigation.

The proposal covers roughly 76,000 remaining ovarian-talc claims and requires participation by firms representing at least 95% of them. J&J would commit $5.5bn, with a first payment of no more than $3bn in 2027 and nothing further before 2028. It lands below the $8.9bn J&J proposed in 2023 and follows two failed attempts to route the claims through bankruptcy. A parallel case runs in the UK.

• Johnson & Johnson Announces a Proposed Resolution of Ovarian Talc Litigation

Tuesday 28 July

GSK will move its R&D HQ to Cambridge and cut £1.9bn annual cost by 2029.

The Cambridge Biomedical Campus centre replace GSK’s Stevenage site and house >1,000 scientists across oncology, respiratory, hepatology, vaccines and HIV. GSK targets £1.9bn in annual savings for £2.4bn of costs over three years, mainly through procurement, simpler processes and shifting resources from mature products. It now plans 20+ phase 3 starts in 2026, double its previous target, and booked a £1.3bn impairment, mostly on chronic-cough drug camlipixant. Q2 turnover was £8.4bn.

• GSK delivers strong Q2 core results performance and continued momentum

CMS will end subsidy holding down standalone Medicare drug-plan premiums.

Centers for Medicare & Medicaid Services (CMS) said it will close the Part D Premium Stabilization Demonstration at the end of 2026, having judged that from 2027 bids that insurers can now price plans without the support. The programme has subsidised standalone Part D plans across 2025 and 2026 to blunt premium rises, so its removal exposes enrollees to sharper increases next year.

• July 28, 2026 Medicare Parts C & D Announcement - CMS

Wednesday 29 July

Prime Minister Andy Burnham asked the Casey commission to set out how to deliver a National Care Service for England.

In a speech, Burnham announced Baroness Louise Casey’s Independent Commission on Adult Social Care will deliver final recommendations by summer 2027 for a service built around the person and integrated with the NHS. He said care workers should be “the best paid people in society, not the worst“. Casey has argued for a mixed market while criticising some private providers for profiteering. It is the new government’s attempt to reopen a reform successive administrations have left unresolved.

• Prime Minister’s speech on social care: 29 July 2026 - Prime Minister’s Office

The FTC sued Hims & Hers, alleging it shared users’ health data with advertisers after promising to protect it.

The complaint, filed with the State of Utah and Los Angeles County in California federal court, says the telehealth company passed lists of customers identified by condition or treatment to Meta, Snap and others through tracking pixels, and locked subscribers into plans while making cancellation hard. It invokes the FTC Act and the Restore Online Shoppers’ Confidence Act. Hims & Hers, a major telehealth supplier of weight-loss drugs, called the claims baseless.

• FTC & States Act Against Hims & Hers for Deceptive and Unlawful Privacy Practices

J&J took a $2.6bn option to buy in vivo CAR-T company Sail Biomedicines.

J&J will pay $785m up front, including $465m in equity, plus up to $140m in milestones, and $2.58bn more if it exercises the option. Sail, built by Flagship Pioneering, develops RNA medicines that engineer a patient’s T cells inside the body rather than in a manufacturing suite, which is designed to dramatically simplify cell therapy manufacture. Buying an option rather than the company lets J&J hold the position while the data matures.

• J&J Collaboration with Sail Biomedicines to Advance in vivo CAR-T Programs

Biogen raised its 2026 guidance as Leqembi recorded its best quarter.

Global Leqembi (lecanemab) sales, shared with Eisai, rose 15% to $184m, a third straight quarter of growth for an Alzheimer’s antibody held back since approval by its infusion schedule and brain imaging. Q2 revenue of $2.74bn beat consensus, and Biogen improved its full-year revenue outlook from a mid-single-digit decline to an increase. Newer drugs, including the Apellis-acquired Syfovre and Empaveli, now outweigh the declining multiple sclerosis business.

• Biogen Reports Second Quarter 2026 Results

An FDA advisory committee voted against Capricor’s Duchenne cell therapy.

The panel voted 9 to 3 that the efficacy data did not support deramiocel for the heart-muscle damage of DMD. The vote does not bind FDA, which has a 22 August decision date, but a negative vote leaves little room to approve without more evidence.

• Capricor Provides Update on FDA Advisory Committee Meeting for Deramiocel

Latigo’s non-opioid painkiller succeeded in a mid-stage trial, putting a second drug into a field Vertex has had to itself.

Published in the New England Journal of Medicine (NEJM), a phase 2b trial in 343 abdominoplasty patients found LTG-001 reduced 48-hour pain versus placebo. Latigo said the high dose delivered about 50% greater SPID48 than Vicodin, with 52% of patients opioid-free versus 22% on placebo. Vertex secured the class’s first approval with Journavx; a credible rival now complicates the market for payers and partners. Latigo, which is pursuing an IPO, plans phase 3 trials in H2 2026.

• Latigo: NEJM Publication of Positive LTG-001 Abdominoplasty Clinical Trial Results

Biopharma dealmaking hit a record $170bn in the first half of 2026, on fewer but larger transactions.

BioWorld put H1 deal value at $170.1bn, 22% above the $139.4bn of H1 2025 and the highest first half in its records, with the second quarter alone a record $90.4bn. The deal count fell to 579 from 636, so the increase was driven by bigger deals. The patent cliff is a key driver, to shore up big pharma’s next decade of revenue.

• Biopharma shatters quarterly deal record with $90.4B Q2 haul - BioWorld

Thursday 30 July

Sanofi upgraded its 2026 guidance but cleared out late-stage immunology programmes under new chief executive Belen Garijo.

Q2 sales rose 17.8% to €11.6bn, led by Dupixent up 37.6%, and Sanofi lifted full-year guidance to around 10% sales growth. Against that, Garijo discontinued the Regeneron-partnered IL-33 antibody itepekimab in COPD and chronic rhinosinusitis and the balinatunfib programmes, and impaired the Kymab-derived amlitelimab by €952m, part of write-offs of over €1bn. It was her first account of how she means to reverse a run of clinical setbacks: an R&D cleanup, more M&A and a push into China.

• Q2 26: double-digit sales and strong EPS growth; 2026 guidance upgraded - Sanofi

An FDA adcom backed Replimune’s twice-rejected melanoma drug, 10 to 3.

The panel found the efficacy of RP1 (vusolimogene oderparepvec) with Opdivo clinically meaningful in melanoma that has progressed on anti-PD-1 therapy, days after FDA reviewers said in briefing documents that the registrational IGNYTE trial did not prove RP1 works. The vote does not bind FDA, which has a 2 August decision date.

• Replimune Announces Favorable Outcome of FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee Meeting for RP1 in Advanced Melanoma

Alnylam cut its TTR sales outlook as Amvuttra hit a $1bn+ quarter for first time.

TTR revenue reached $1.03bn, up 89%, taking total product sales to $1.17bn, but Alnylam trimmed full-year TTR guidance by $200m to $4.2 to $4.5bn, saying early second-line demand had been inflated by pent-up switching that has now normalised. Amvuttra (vutrisiran) makes up most of Alnylam’s commercial weight.

• Alnylam Pharmaceuticals Reports Second Quarter 2026 Financial Results

Endpoints reported that the first round of Trump’s 100% pharmaceutical tariffs will not take effect as planned, every targeted company having dealt itself out.

The first Section 232 tariffs were due to hit an initial group of drugmakers, but all had secured Most Favoured Nation pricing and US onshoring deals setting their rate at 0%, leaving none to charge. The 100% tariff remains scheduled for the rest of the industry from 29 September, as the White House presses more firms into agreements.

• 1st round of Trump’s 100% pharma tariffs won’t start Friday as planned - Endpoints

A US appeals court revived claims that decongestant makers misled buyers with “maximum strength” labelling.

The Second Circuit ruled that “maximum strength“ claims over phenylephrine products can proceed. The FDA has concluded that oral phenylephrine works no better than placebo. The consolidated litigation covers roughly 100 class actions against makers and retailers including Procter & Gamble and CVS.

• In re Oral Phenylephrine Marketing and Sales Practices Litigation, No. 24-3296 (2d Cir.) - US Court of Appeals for the Second Circuit

Illumina raised its 2026 guidance after a Q2 beat.

The sequencing leader reported Q2 revenue of $1.16bn, up 9.5%, and lifted full-year guidance to $4.60 to $4.64bn and non-GAAP EPS to $5.30 to $5.40, citing NovaSeq X placements and clinical demand, a read across the entire sequencing market.

• Illumina Reports Financial Results for Second Quarter of Fiscal Year 2026

Two biotechs priced or set terms for IPOs

Apnimed priced an upsized offering of 12m shares at $16 to raise $192m, funding the launch of its sleep-apnoea pill AD109, which awaits an FDA decision, and its shares jumped on their Nasdaq debut. Braveheart Bio set terms to raise $318.8m at a valuation of up to $1.2bn, to fund phase 3 work on BHB-1893, a cardiac myosin inhibitor licensed from Jiangsu Hengrui for hypertrophic cardiomyopathy. Analysts attribute the revival to rotation from richly valued tech and AI stocks into healthcare.

• Apnimed Announces Pricing of Upsized Initial Public Offering

• Braveheart Bio, Inc. Form S-1/A - SEC EDGAR

Friday 31 July

Novo’s ziltivekimab failed in its big cardiovascular outcomes trial, shutting its expansion from obesity and diabetes.

In phase 3 ZEUS, the anti-IL-6 antibody engaged its target but failed to reduce major cardiovascular events versus placebo in >6,300 people with atherosclerotic disease, chronic kidney disease and inflammation (hazard ratio 0.99). Cardiovascular outcome trials are among the costliest and determine reimbursement breadth, so failure leaves little room for recovery. Novo’s remaining hopes rest on two trials: HERMES in heart failure and ARTEMIS after heart attack, both of which report in H1 2027.

• Novo update on ZEUS phase 3 trial in people with ASCVD, CKD and inflammation

AstraZeneca and Daiichi Sankyo won EU approval for Datroway in first-line triple-negative breast cancer.

The European Commission cleared Datroway, a TROP2 ADC, as first-line monotherapy for metastatic triple-negative breast cancer in patients ineligible for immunotherapy, moving it ahead of chemotherapy. In phase 3 TROPION-Breast02, overall survival rose to 23.7 months from 18.7 (median) and the risk of progression or death fell 43%. AZ said it is the only EU-approved TROP2 with an overall-survival benefit in this setting.

• Datroway approved in the EU as only TROP2-directed medicine with overall survival benefit for 1st-line metastatic TNBC - AstraZeneca

ALETH · OPEN ACCESS RESEARCH

aleth.co

The Aleth Briefs trace each story to its original source and show how the week unfolded.

The week in five lines

• Burnham abolished the UK science department.

• Biotech M&A hit a new record.

• Trump threatened 200% tariffs on imported generics.

• Tempus AI agreed to acquire Personalis for $1.5bn.

• J&J gained FDA approval for its first robotic surgery system.

In this edition

• Monday: Samsung buys PolyPeptide; GSK drops camlipixant; Kolon phase 3 fail; Tempus buys Personalis

• Tuesday: UK abolishes DSIT; record biotech M&A; Novartis-Myricx ADC; Freenome SPAC

• Wednesday: Trump generic tariffs; Novo sues Lilly; GSK Jideytro approval; Crystalys gout raise; NIH Bio Genesis

• Thursday: Repligen buys BioLife; AstraZeneca EU breast cancer; J&J robotic surgery; Lilly retatrutide

• Friday: FDA backs BPC-157; J&J myeloma combo; GSK strategy update

Monday 20 July

Samsung Biologics agreed to buy Swiss CDMO PolyPeptide Group for $1.8bn.

Samsung is offering CHF 44.31 a share in cash, valuing PolyPeptide’s equity near CHF 1.46bn ($1.8bn), a 40% premium to the undisturbed price on 10 April. PolyPeptide’s board backs the offer and its largest holder, with 55.7% of the shares, has committed to tender. Peptide contract manufacturers have become a choke point in weight-loss drugs. Samsung, until now a monoclonal-antibody house, is buying its way into that. Completion is expected by the end of 2026.

• Samsung Biologics announces tender offer to acquire PolyPeptide Group AG for CHF 44.31 per share - PolyPeptide Group / Samsung Biologics

GSK is stopping development of chronic-cough drug it paid $2bn for.

In the phase 3 CALM programme, CALM-1 hit its primary endpoint, a significant cut in 24-hour cough frequency at week 12 on the 50mg twice-daily dose, but CALM-2 missed the same endpoint at week 24 and the lower 25mg dose failed in both trials. GSK judged the benefit “unlikely to transform patient care” and stopped development in refractory chronic cough. The asset, a P2X3 antagonist it acquired in its 2023 Bellus Health buyout, continues in a phase 2b trial in IBS.

• GSK provides an update on CALM-1 and CALM-2 phase III trials - GSK

Kolon’s gene therapy for knee osteoarthritis failed its first late-stage US trial.

TissueGene-C (TG-C) missed both co-primary endpoints, pain and function, at month 12 in the phase 3 ACTiVION-II study, which the company put down to an unusually strong placebo response. A second late-stage trial, ACTiVION-I, reports in October.

• Kolon TissueGene reports topline ACTiVION-II phase 3 results for TissueGene-C (TG-C) - Kolon TissueGene

Tempus will buy Personalis for $1.5bn adding cancer genomics to its AI platform.

The all-stock deal values Personalis at $16.25 a share, an enterprise value near $1.5bn net of Tempus’s existing stake, with Tempus able to pay up to half in cash. It folds Personalis’s tumour-profiling and molecular residual disease (MRD) testing, including its NeXT Personal assay, into Tempus’s precision-oncology business. Tempus expects to close late in 2026 or early in 2027.

• Tempus to acquire Personalis, integrating MRD - Tempus AI

Tuesday 21 July

New PM Burnham cut the science department and established a Minister for AI.

The Department for Science, Innovation and Technology (DSIT) is being folded into an enlarged Department for Business, Innovation, Science and Trade under Jonathan Reynolds. Patrick Vallance, the former government chief scientific adviser, resigned as science minister. Life sciences leaders welcomed Reynolds’s return but voiced concern at losing both a standalone science department and Vallance. A new Minister for AI, Kanishka Narayan, gets a cabinet seat, with AI strategy moving into the Cabinet Office.

• Ministerial appointments: July 2026 - Prime Minister’s Office (GOV.UK)

• Departure of Lord Vallance as science minister causes concern - The Times

Billion-dollar biotech takeovers in 2026 have already passed the whole of 2025.

The Financial Times counted 37 acquisitions of $1bn or more so far in 2026, topping last year’s full-year record of 35 with five months still to run. The engine is the patent cliff: big pharma is sitting on cash from today’s blockbusters and buying its next decade of revenue. The 2026 trend is broad, with every major and a widening group of mid-sized and specialist buyers in the market.

• Fervour over top-selling drugs fuels record biotech dealmaking - Financial Times

Novartis provided further colour on its $1.5bn Myricx Bio acquisition.

Chief executive Vas Narasimhan defended the deal on this week’s Q2 call. Struck earlier in July, it brings Novartis Myricx’s N-myristoyltransferase inhibitor payload, a different way of killing tumour cells from the ADCs already crowding oncology. Narasimhan, who had sat out the ADC land grab, said he moved because the chemistry was novel: “we would certainly look to expand that NMTi payload across more delivery vehicles and more drug targets.”

• Novartis agrees to acquire Myricx Bio, advancing next-generation ADC innovation with a novel NMTi payload - Novartis

• “We’ve been looking for a novel approach”: Why Novartis CEO ended his ADC holdout for the $1.5B Myricx deal - Fierce Biotech

Freenome went public through a $310m SPAC.

The multi-cancer early detection (MCED) company completed its combination with Perceptive Capital Solutions Corp and began trading on Nasdaq as FRNM, raising $310m gross. The listing, agreed with the Perceptive Advisors vehicle in December, hands one of the larger private names in liquid-biopsy screening public-market capital to push its colorectal and multi-cancer tests toward commercialisation.

• Freenome debuts as a publicly traded company focused on blood-based early cancer detection - Freenome

Wednesday 22 July

Trump set a countdown to a 200% tariff on imported generic drugs

Generics escape duty for two years, then face a 100% tariff from August 2028 and 200% a year after that, unless their makers build in the US. The president cast it as reshoring “with a penalty to those Companies that decide not to build.” The exposure is real: generics are about 90% of US scripts and most are imported, >50% from India alone. Sandoz, among the largest suppliers, said it shares the affordability goal and would keep talking to Washington but that it was “too early to assess” the impact.

• Truth Social post on a 200% tariff on imported generic drugs - Donald J. Trump, Truth Social

• Sandoz to engage with US policymakers after Trump’s tariff plan - The Wall Street Journal

Novo Nordisk took Eli Lilly to court over false advertising of weight-loss drugs.

In a complaint filed in New Jersey federal court, Novo alleges Lilly ran “false and materially misleading“ ads for Zepbound and Mounjaro, “intentionally selected outdated studies,” and set its top doses against lower doses of Wegovy and Ozempic while leaving out newer high-dose semaglutide data. It wants an injunction and corrective advertising. Lilly’s campaign leans on the SURMOUNT-5 head-to-head trial where tirzepatide beat semaglutide on weight loss: “the only head-to-head, randomized clinical trial“.

• Novo Nordisk v. Eli Lilly, complaint, D.N.J. (3:26-cv-09027) - Novo Nordisk / STAT News

The FDA approved GSK’s cancer drug Jideytro, a week after its $10.6bn buyout.

Jideytro (zidesamtinib), a brain-penetrant ROS1 inhibitor, cleared for ROS1-positive non-small cell lung cancer in patients already treated with a ROS1 drug, nearly two months ahead of its September action date. It is GSK’s first approved lung-cancer medicine, and it arrived through Nuvalent, whose ~$10.6bn takeover GSK completed on 15 July. Approval rested on the phase 1/2 ARROS-1 trial, in which 44% of patients responded.

• Jideytro (zidesamtinib) approved in the US for previously treated ROS1-positive NSCLC - GSK

• GSK completes acquisition of Nuvalent, Inc. - GSK

Crystalys raised $130m to push its once-daily gout pill into phase 3.

The Series B, led by Frazier Life Sciences alongside existing backers Novo Holdings and SR One, funds registration trials for dotinurad, an oral URAT1 inhibitor that lowers uric acid and is already approved across much of Asia. It follows a $205m Series A only ten months earlier, in September 2025.

• Crystalys Therapeutics announces $130 million Series B financing to advance global phase 3 development of dotinurad for gout - Crystalys Therapeutics

The NIH put its weight behind AI, launching a $1.2bn Bio Genesis Mission.

The programme is the health agency’s slice of a wider federal Genesis Mission, set up by a November 2025 executive order to point AI at scientific problems across government. NIH names six targets, from forecasting biological systems to speeding drug development, and its director, Jay Bhattacharya, set a goal of halving the time from discovery to patient over ten years.

• Genesis Mission: harnessing AI to transform American science - The White House

Thursday 23 July

Repligen agreed to buy BioLife Solutions for about $1.5bn

BioLife makes the biopreservation media and freezing products that keep cell and gene therapies alive from manufacturing to patient, so the deal moves Repligen further into that supply chain rather than into a drug. Terms are $31.00 a share, split $11.25 in cash and 0.1442 of a Repligen share, a 24% premium to the 90-day average, with close expected in Q4.

• Repligen to acquire BioLife Solutions, expanding its cell-therapy capabilities - Repligen / BioLife Solutions

AstraZeneca won EU approval for its oral breast-cancer pill Etcamah

Etcamah (camizestrant), a next-generation oral selective estrogen receptor degrader (SERD), is cleared with a CDK4/6 inhibitor for ER-positive, HER2-negative advanced breast cancer once a tumour picks up an ESR1 mutation during first-line treatment. In the phase 3 SERENA-6 trial the combination cut the risk of progression or death by 56% (hazard ratio 0.44), lifting median progression-free survival to 16.0 months from 9.2. The FDA has extended its review in the US approval process.

• Etcamah (camizestrant) approved in the EU for ESR1-mutant advanced breast cancer - AstraZeneca

J&J was cleared by the FDA to enter the surgical robotics market.

The agency granted De Novo authorisation to J&J’s Ottava system, a soft-tissue surgical robot with its arms built into the operating table rather than mounted on carts, for a broad set of general-surgery procedures. It sets up a three-way US contest with Intuitive Surgical‘s da Vinci, which holds about 80% of the market, and Medtronic‘s Hugo. J&J will start with selected US hospitals while it seeks more indications.

• Johnson & Johnson receives FDA market authorization in the US for its OTTAVA Robotic Surgical System - Johnson & Johnson

Lilly’s retatrutide posted the largest phase 3 weight loss yet reported for an obesity drug, but did not significantly reduce cardiac events.

In two phase 3 trials, the triple hormone agonist (”triple-G”) took up to 22.6% off patients’ weight at 80 weeks, ahead of the GLP-1 drugs already on sale. But in TRIUMPH-3, run in people with established cardiovascular disease, it did not significantly cut major cardiac events, the hazard ratio of 0.82 too wide to tell apart from chance. The peak figure also came in below the roughly 24% seen in phase 2. Lilly plans to file for approval in Q1 2027.

• Lilly’s triple-agonist retatrutide successful in two additional phase 3 trials - Eli Lilly

Friday 24 July

An FDA advisory panel voted to loosen the rules on a barely characterised peptide, over its own scientists’ objections.

By 8 votes to 6, with one abstention, the Pharmacy Compounding Advisory Committee recommended adding BPC-157, alongside a second peptide, KPV, to the substances pharmacies may compound. FDA staff had advised against, citing a lack of evidence that BPC-157 works and a warning of low confidence in what the substance even is. Most of the members who voted yes have ties to the peptide industry, on a panel remade under Health Secretary Robert F. Kennedy Jr. The recommendation is non-binding.

• Certain bulk drug substances for use in compounding that may present significant safety risks - FDA

J&J reported that pairing two of its bispecific antibodies cut the risk of myeloma getting worse by 89%.

In the phase 3 MonumenTAL-6 trial, the combination of Tecvayli (teclistamab) and Talvey (talquetamab), which hit two different targets, BCMA and GPRC5D, reduced the risk of disease progression or death by 89% (hazard ratio 0.11) and the risk of death by 62% against standard care, in patients with relapsed or refractory disease. J&J said the hazard ratio was the lowest yet reported for a bispecific combination in a phase 3 myeloma trial. The result strengthens J&J’s already leading myeloma franchise.

• Tecvayli and Talvey reduced the risk of disease progression or death by 89% in earlier-line relapsed/refractory multiple myeloma - J&J

GSK’s new CEO, Luke Miels, will set out his strategy next week.

The company has scheduled its Q2 results and a “portfolio growth opportunities” update in London for 28 July, and insiders expect the depth of the R&D pipeline, and an emerging oncology portfolio, to be the centrepiece. Miels, previously chief commercial officer, has already spent to reshape that pipeline, through the acquisitions of RAPT and Nuvalent.

• GSK chief Luke Miels to host first major strategy update - The Times

ALETH · OPEN ACCESS RESEARCH

aleth.co

The Aleth Briefs trace each story to its original source and show how the week unfolded.

The week in five lines:

• CagriSema lost to Zepbound head-to-head.

• Gilead agreed to buy Arcellx for $7.8bn.

• The FDA proposed a pathway for bespoke genetic medicines.

• Roche unveiled its $150 human genome Axelios instrument platform at AGBT.

• Novo Nordisk will cut US semaglutide list prices to $675.

Browse by day:

• Weekend catch-up: US tariffs

• Monday: CagriSema · Arcellx · FDA pathway · Gossamer · Merck · BioMarin · Ultima

• Tuesday: Novo prices · Braftovi · US vaccine suit

• Wednesday: GSK-35Pharma · HIV pills

• Thursday: Lilly pill · argenx · BMS ADC · Aicuris · Hernexeos · Generate IPO

• Friday: Illumina · Oxford Nanopore

Weekend catch-up

The US Supreme Court struck down Trump’s global tariffs, while pharma escaped the replacement.

The court ruled 6-3 that the International Emergency Economic Powers Act does not give the president authority to impose tariffs. The White House responded the same day with a temporary 10% import surcharge under section 122 of the Trade Act, but pharmaceuticals and APIs were exempted. Drugmakers had spent the prior year restructuring supply chains around the now-invalidated regime. The immediate threat has receded, but the authority to target pharma through other statutes survives.

• Learning Resources v Trump, slip opinion of 20 February · Supreme Court

• Imposing temporary import surcharge, presidential proclamation · The White House

Monday 23 February

Novo Nordisk’s CagriSema failed its head-to-head with Zepbound.

In the open-label REDEFINE 4 trial Novo’s CagriSema - a combination of cagrilintide, an amylin analogue, and semaglutide - failed to show non-inferiority on weight loss versus Lilly’s single-molecule dual GIP/GLP-1 agonist Zepbound (tirzepatide) 15 mg at 84 weeks. CagriSema delivered 20.2% weight loss against 23.6% for tirzepatide.

CagriSema was Novo’s best shot at closing the efficacy gap with Zepbound, and the head-to-head result leaves Lilly clearly ahead for now. A higher-dose CagriSema study starts in H2 2026, with REDEFINE 11 reporting H1 2027. An FDA decision on the filed dose is expected by late 2026. Novo shares fell >12% in early Copenhagen trading.

• REDEFINE 4 head-to-head trial, primary endpoint not achieved · Novo Nordisk

Gilead agreed to buy Arcellx for $7.8bn.

Gilead will pay $115/share in cash plus a $5 contingent value right, converting its 2022 anito-cel collaboration into full ownership and eliminating its existing profit share, milestones and royalties. Arcellx’s BCMA CAR-T is already under FDA review in fourth-line multiple myeloma, with a decision due by 23 December 2026. The deal gives Gilead full control of one of the leading challengers to J&J’s Carvykti and adds another major asset to a cell therapy franchise led by Yescarta and Tecartus.

• Gilead to acquire Arcellx to maximize long-term potential of anito-cel · Gilead

The FDA proposed a pathway for bespoke genetic medicines.

The Plausible Mechanism Framework for individualised therapies targets genetic diseases with a known biological cause. Rather than follow conventional development, the FDA would allow evidence on bespoke treatments from related products, mechanistic understanding and prior manufacturing experience to support approval.

The framework formalises the kind of case-by-case approach used for therapies such as the custom CRISPR treatment given to baby KJ. If it works as intended, it could materially shorten development timelines for ultra-rare genetic diseases.

• Plausible Mechanism Framework to develop individualized therapies · FDA

Gossamer Bio’s seralutinib failed its phase 3 in pulmonary arterial hypertension.

The inhaled PDGFR inhibitor improved six-minute walk distance by a placebo-adjusted 13.3 metres at week 24, but missed the trial’s prespecified statistical threshold despite a nominal p=0.0320. Seralutinib had been positioned as the nearest challenger to Merck & Co’s Winrevair. Gossamer shares fell 77%. Enrolment in the follow-on SERANATA study was paused, and the company plans to discuss a path forward with the FDA. Chiesi co-develops the drug.

• Gossamer Bio announces topline results from the phase 3 PROSERA study · Gossamer Bio

Merck is splitting its human health business ahead of the Keytruda patent cliff.

Oncology will become a standalone division under Jannie Oosthuizen, while a separate specialty, pharma and infectious diseases unit will be led by Brian Foard, joining from Sanofi. Keytruda generated $31.7bn of Merck’s $58.1bn pharma sales in 2025 and loses US exclusivity in 2028. The new structure gives oncology its own leadership while focusing on the portfolio that must replace Keytruda’s earnings.

• Merck evolves operating structure to support portfolio execution · Merck & Co

Astellas took co-rights to Vir’s masked T-cell engager for prostate cancer in a deal worth up to $1.7bn.

Vir gets $335m upfront and near-term milestones for VIR-5500, a dual-masked PSMA T-cell engager in phase 1 prostate cancer. The companies split US profit and loss equally, with Vir eligible for another $1.37bn plus ex-US royalties. The deal funds Vir’s oncology push and gives Astellas another prostate cancer asset alongside Xtandi.

• Astellas & Vir announce global strategic collaboration VIR-5500 · Vir Biotechnology

BioMarin is pulling its haemophilia A gene therapy Roctavian from the market.

The withdrawal follows October’s decision to seek a buyer. None emerged, and BioMarin says the move is unrelated to efficacy or safety. Approved in Europe in 2022 and the US in 2023 at a $2.9m list price, Roctavian never achieved expected uptake, highlighting that one-time gene therapies with imperfect durability are commercially difficult at multi-million-dollar prices, particularly where existing treatment is strong.

• BioMarin voluntarily withdraws Roctavian from the market · BioMarin

Ultima Genomics launched its UG200 sequencing series at AGBT.

The UG200 and UG200 Ultra run the company’s Solaris 2.0 workflows, with the Ultra targeting more than 60,000 30x genomes a year. US pricing starts at $850,000, with shipments due from Q2. Ultima is pushing further into the high-throughput sequencing market where Illumina has historically been strongest.

• Next generation sequencing at scale with UG200 Series launch · Ultima Genomics

Tuesday 24 February

Novo Nordisk will reset US semaglutide list prices to $675.

From January 2027, Wegovy, Ozempic and Rybelsus will all list at $675 a month, cutting Wegovy’s sticker price by half. Net prices are already substantially lower after rebates, so the immediate revenue effect may be limited, but the move further dismantles the old $1,000-plus per month US GLP-1 pricing model.

• Significant reduction US list price for Wegovy, Ozempic and Rybelsus · Novo Nordisk

Pfizer’s Braftovi combination won full approval in first-line colorectal cancer.

The FDA converted Braftovi (encorafenib) with Erbitux (cetuximab) and chemotherapy to full approval in BRAF V600E-mutant metastatic colorectal cancer. BREAKWATER showed a 51% reduction in the risk of death, removing the confirmatory-data overhang for the only targeted first-line regimen in this population.

• US FDA grants full approval to Pfizer’s Braftovi combination regimen · Pfizer

15 US states sued the federal government over the childhood vaccines schedule.

The lawsuit challenges the January decision that removed seven vaccines from universal recommendation, including hepatitis A and B, influenza, Covid-19 and RSV, as well as the replacement of ACIP’s membership. The states are asking the court to overturn both, moving the dispute over US vaccine policy into the courts.

• Multistate lawsuit challenging Kennedy vaccine schedule · Arizona Attorney General

Wednesday 25 February

GSK agreed to buy 35Pharma for $950m in cash.

The Canadian biotech’s lead asset HS235 is a clinical-stage activin signalling inhibitor for pulmonary arterial hypertension (PAH) and PH with preserved ejection fraction heart failure. The pathway is validated by Merck’s Winrevair, which sold $1.4bn last year. HS235 data suggest fat-selective weight loss and improved insulin sensitivity. GSK’s move comes two days after Gossamer’s failure thinned the PAH pipeline.

• GSK enters agreement to acquire 35Pharma Inc · GSK

Gilead and Merck both reported late-stage data for new daily HIV pills.

Gilead’s bictegravir/lenacapavir single tablet maintained virological suppression in switch patients in ARTISTRY-1, while Merck reported phase 3 data for its two-drug doravirine/islatravir regimen. Both companies plan regulatory filings, as they try to simplify daily oral therapy even as longer-acting regimens move toward weekly dosing.

• Single tablet bictegravir & lenacapavir maintained virological suppression · Gilead

• Late-breaking data three phase 3 trials evaluating doravirine/islatravir · Merck & Co

Thursday 26 February

Lilly’s orforglipron beat Rybelsus in a head-to-head diabetes trial.

In ACHIEVE-3, orforglipron 36 mg reduced A1C by 2.2% versus 1.4% for Rybelsus 14 mg on the efficacy estimand, with 9.2% weight loss versus 5.3%. On the treatment-regimen estimand, the gap narrowed to 1.9% versus 1.5%. Adverse-event discontinuations were roughly twice as high with orforglipron.

Three days after Zepbound beat CagriSema head-to-head, this compounds a difficult week of direct comparisons for Novo. Orforglipron is filed in >40 countries. As a small molecule it offers Lilly easier manufacturing and supply than peptide GLP-1s.

• Lilly’s oral GLP-1, orforglipron, delivered superior blood sugar control and weight loss compared to oral semaglutide · Eli Lilly

argenx’s Vyvgart succeeded in ocular myasthenia gravis.

The phase 3 ADAPT OCULUS trial met its primary endpoint, with no new safety signals, supporting a US filing to expand Vyvgart into the ocular form of the disease. It is the first registrational study of a targeted treatment in ocular myasthenia gravis.

• Vyvgart phase 3 ADAPT OCULUS data in ocular myasthenia gravis · argenx

BMS and SystImmune’s bispecific ADC hit survival endpoints in breast cancer.

Izalontamab brengitecan, the EGFRxHER3 ADC BMS licensed for $800m upfront in 2023, improved both progression-free and overall survival at an interim analysis of a Chinese phase 3 trial in triple-negative breast cancer. It is the drug’s third positive phase 3 result and the first dual PFS/OS win for a bispecific ADC in the disease.

• Positive phase III topline results izalontamab brengitecan · Bristol Myers Squibb

Asahi Kasei agreed to buy Germany’s Aicuris for €780m.

The Japanese group is acquiring the antiviral specialist through US subsidiary Veloxis, gaining the Prevymis royalty stream and pritelivir, which met its phase 3 primary endpoint in refractory herpes simplex infection in immunocompromised patients. The deal adds a focused infectious-disease portfolio built around transplant medicine.

• Asahi Kasei to acquire Aicuris to accelerate growth in infectious diseases · Aicuris

Hernexeos won rapid first-line approval in lung cancer, only 44 days after filing.

The FDA granted accelerated approval to Boehringer Ingelheim’s Hernexeos for first line HER2-mutant non-small cell lung cancer, based on a 76% response rate in treatment-naive patients. It is the second approval through the National Priority Voucher route, giving an early indication of how quickly the pathway can move.

• FDA approves Hernexeos for first-line lung cancer · Boehringer Ingelheim

Caris reported interim data on its multi-cancer blood test.

In 2,122 samples from Achieve 1, Caris Detect showed 56.8% sensitivity at stage I, rising to 99.1% at stage IV. Specificity was 99.1% in 121 asymptomatic participants and 95.3% in the 1,505-person undiagnosed population. A blinded validation in about 865 held-out samples is due later in Q1.

• Caris Life Sciences completes interim readout of Achieve 1 study · Caris Life Sciences

Roche unveiled its Axelios sequencer, targeting a $150 human genome.

Roche revealed details of its sequencing-by-expansion chemistry in early 2025. At AGBT it unveiled the instrument, Axelios 1, which is due to launch later this year, targeting a $150 whole human genome at scale. Roche will enter the sequencing market with an instrument, an aggressive cost claim and the balance sheet to compete, adding further pressure on Illumina and its emerging challengers.

Advances in Genome Biology and Technology (AGBT) · Roche

Generate Biomedicines priced its IPO at $400m.

The Flagship-founded protein design company sold 25m shares on Nasdaq at $16. Trading under GENB begins Friday. Its lead asset, GB-0895, is an AI-engineered anti-TSLP antibody already in phase 3 severe asthma trials, with twice-yearly dosing under evaluation. The IPO is therefore a relatively advanced public-market test of generative protein design rather than another preclinical AI platform story.

• Generate Biomedicines announces pricing of IPO · Generate Biomedicines

Friday 27 February

Illumina launched TruPath Genome and detailed its NovaSeq X roadmap at AGBT.

TruPath Genome is designed to compete with long-read sequencing, which Illumina says doubles the throughput of competing long-read methods. The company also outlined an 18-month NovaSeq X roadmap increasing output 40% to 35bn reads per flow cell, alongside Q70 duplex accuracy for specialised high-sensitivity applications.

• Illumina launches TruPath Genome, unveils NovaSeq X roadmap · Illumina

MGI conceded its sequencer infringes Oxford Nanopore’s Australian patents.

MGI accepted in the Federal Court (Australia) that its Cyclone SEQ WT02 infringes four Oxford Nanopore patents, leaving infringement itself undisputed ahead of a 2027 trial on remaining defences and damages. Separate UK High Court proceedings against MGI/BGI entities continue over trade-secret infringement and breach of confidence.

• Update on legal action against MGI Australia · Oxford Nanopore

ALETH · OPEN ACCESS RESEARCH

aleth.co

The Aleth Briefs trace each story to its original source and show how the week unfolded.

The week in five lines:

• Grail’s Galleri missed its NHS trial primary endpoint, shares fell >45%.

• Danaher and Masimo agreed a deal at about $9.9bn enterprise value.

• An FDA NEJM article suggests one pivotal trial could become the approval default.

• Bayer proposed a $7.25bn Roundup class settlement.

• Compass Pathways’ COMP360 met its second phase 3 primary endpoint.

Browse by day:

• Weekend catch-up: Gilead-Genhouse · Disc Medicine

• Monday: Roche Gazyva · Novartis on the UK

• Tuesday: Danaher-Masimo · Bayer · Compass · Ocular · CSL-Lilly

• Wednesday: FDA one-trial · Moderna

• Thursday: Grail · AZ Calquence · Hims-Eucalyptus · Guardant-MetaSight · Element

Weekend catch-up

Gilead took global rights to a clinic-ready cancer drug GH31 from China’s Genhouse Bio for $80m upfront, in a deal worth up to $1.45bn in milestones.

GH31 is a MAT2A inhibitor, a synthetic lethality approach aimed at MTAP-deleted tumours, with clearance to enter clinical trials in both the US and China. Gilead takes worldwide development and commercialisation. The deal adds to the run of US buyers sourcing clinic-ready oncology assets from Chinese biotechs.

• Global partnership with Gilead on MAT2A inhibitor GH31 · Genhouse Bio

The FDA issued a complete response letter for Disc Medicine’s bitopertin.

The FDA asked for results for the erythropoietic protoporphyria candidate from the continuing APOLLO phase 3 study. The application had carried a Commissioner’s National Priority Voucher, meant to speed favoured drugs through review. The letter resets the timeline on Disc’s lead asset without ending the programme.

• Complete response letter from FDA for bitopertin · Disc Medicine

Monday 16 February

Roche’s Gazyva (obinutuzumab) delivered positive phase 3 results in primary membranous nephropathy.

The results could support the first approval in the kidney disease and further extend use of the oncology antibody into immune-mediated conditions, following its clearance in lupus nephritis last autumn.

• Positive phase III results for Gazyva in primary membranous nephropathy · Roche

Novartis’s UK and Ireland head said the NHS’s reformed approach to evaluating new medicines is “slowly killing the life science sector in the UK”.

Johan Kahlstrom told The Times the changes still do not go far enough. The criticism follows 15 years of Novartis cutting back its UK footprint, which the company attributes to NICE’s cost-effectiveness rules limiting access to its medicines. Novartis has repeatedly described the UK as “uninvestable”.

Novartis’s UK chief says NHS medicines assessment is throttling the sector · The Times

Tuesday 17 February

Danaher agreed to buy Masimo for $9.9bn.

Danaher will pay $180/sh in cash, valuing Masimo at $9.9bn including debt. The deal adds pulse oximetry, sensor technology and AI-enabled patient monitoring to Danaher’s diagnostics portfolio, where Masimo will sit alongside Radiometer, Leica, Cepheid and Beckman Coulter. Danaher expects Masimo to generate >$530m EBITDA in 2027, with >$125m of cost and $50m of revenue synergies by year five. The price is around 18x 2027 EBITDA, falling to 15x including expected synergies. Closing H2 2026.

• Danaher to acquire Masimo Corporation · Danaher

Bayer proposed a $7.25bn settlement of the Roundup litigation.

The Monsanto US class settlement would resolve current and future claims alleging Roundup causes cancer. The litigation has weighed on Bayer since its 2018 acquisition of Monsanto. The proposed settlement would cap a long-running legal exposure that has been difficult to quantify and reduce the risk of years of further litigation.

• Roundup class settlement agreement to resolve current and future claims · Bayer

Compass Pathways’ synthetic psilocybin met its endpoint in a second phase 3 trial.

COMP360, a synthetic formulation of psilocybin, the psychoactive compound found in “magic mushrooms”, met the primary endpoint in the second of two phase 3 trials in treatment-resistant depression. Shares rose about 30%. Compass has requested an FDA meeting to discuss a rolling submission and expects to complete its NDA in Q4.

• Met primary endpoint 2nd phase 3 trial of COMP360 psilocybin · Compass Pathways

Ocular Therapeutix’s AXPAXLI beat a single aflibercept dose in phase 3, but shares fell more than 25%.

SOL-1 compared one dose of the axitinib intravitreal implant with a single 2 mg dose of Eylea in wet AMD after an aflibercept loading phase, rather than with continued on-label anti-VEGF treatment. AXPAXLI met the trial’s superiority endpoint, supporting planned FDA discussions, but the comparator design tempered investor enthusiasm.

• Positive results from SOL-1 phase 3 superiority trial in wet AMD · Ocular Therapeutix

Eli Lilly licensed CSL’s anti-IL-6 antibody clazakizumab for $100m upfront.

Lilly will explore the antibody in kidney disease and other immuno-inflammatory indications, with CSL eligible for additional milestones and royalties. Clazakizumab previously failed a phase 3 trial in organ transplant rejection, and the licence allows CSL to retain some of the economics without fully funding further development alone.

• CSL and Lilly enter licensing agreement for clazakizumab · CSL

The UK government cleared the way for UK Biobank to receive its participants’ GP records.

A data provision notice published on 10 February, picked up this week by The Times, opens coded primary care data in England to consented cohorts such as UK Biobank. For its 500,000 participants, this could double recorded cases of common conditions including arthritis, asthma, dementia and heart failure. The data cover diagnoses, symptoms, medications, referrals and test results, with identifiers removed and consultation notes excluded. Access starts once the NHS agrees data-sharing terms.

• Milestone for health research Government enables access to GP data · UK Biobank

• Decades of medical insight unlocked as UK Biobank gets GP records · The Times

Wednesday 18 February

FDA moves towards one pivotal trial as its default for drug approval.

Commissioner Marty Makary and Vinay Prasad argued in a New England Journal of Medicine perspective that requiring two pivotal trials has become something of a regulatory dogma, and that one adequate well-controlled trial plus confirmatory evidence should instead be the default. FDA already allowed this, but making it the norm would materially change development planning. Formal guidance is still to come.

• One pivotal trial, the new default for FDA approval ending two-trial dogma · NEJM

The FDA reversed itself and will review Moderna’s flu vaccine, a week after refusing to file the application.

After a Type A meeting with CBER, Moderna proposed a revised regulatory pathway for mRNA-1010: full approval in adults aged 50-64 and accelerated approval in ages 65 and over, with an additional post-marketing study in older adults. FDA accepted the amended BLA and set a 5 August PDUFA date, in time for the 2026–27 flu season.

• FDA will initiate review of seasonal influenza vaccine submission · Moderna

Thursday 19 February

Grail’s Galleri missed its primary endpoint in the NHS-Galleri trial.

The study was the largest test so far of whether a single blood test can detect multiple cancers early enough to improve outcomes, and was central to Grail’s UK strategy. It missed its primary endpoint, sending shares down >45% after hours on Thursday.

Grail highlighted a substantial reduction in stage IV diagnoses and a four-fold increase in cancer detection, but the primary endpoint failure weakens the case for NHS adoption and raises fresh questions over the clinical value of multi-cancer early detection (MCED) screening. FDA premarket approval remains under review.

• NHS-Galleri demonstrates substantial reduction in stage IV cancer diagnoses · Grail

The FDA approved AstraZeneca’s Calquence with Venclexta as the first all-oral, fixed-duration combination for first-line chronic lymphocytic leukaemia (CLL).

The clearance covers adults with untreated CLL or small lymphocytic lymphoma (SLL). It gives AZ a fixed-duration front-line regimen in a market where treatment duration has become an important point of differentiation among BTK-based therapies.

• FDA approves acalabrutinib with venetoclax for CLL or SLL · FDA

• Approved as first all-oral, fixed-duration combination in 1st-line CLL · AstraZeneca

Hims & Hers agreed to buy Australian digital health company Eucalyptus for $240m upfront, in a deal worth up to $1.15bn.

The acquisition expands Hims further beyond the US into Australia and Japan and increases its presence in Germany, Canada and UK. Eucalyptus also adds prescribing and fulfilment infrastructure to support Hims’ international weight-loss business.

• To acquire Eucalyptus, accelerating global consumer health vision · Hims & Hers

Guardant disclosed its December acquisition of MCED startup MetaSight.

Terms were $59m upfront, with up to $90m tied to regulatory and commercial milestones. The acquisition adds a multi-cancer early detection programme to a screening portfolio currently centred on blood-based colorectal cancer testing.

• Q4 and full-year 2025 results and 2026 outlook · Guardant Health

Element unveiled VITARI, a new high-throughput sequencing platform.

Element Biosciences has been pushing into territory held by Illumina and Ultima Genomics with its AVITI line, and its new high-throughput instrument takes the fight to the part of the market that drives the majority of sequencing consumables revenue.

• Element introduces VITARI, redefining what sequencing makes possible · Element

ALETH · OPEN ACCESS RESEARCH

aleth.co

The Aleth Briefs trace each story to its original source and show how the week unfolded.

The week in five lines:

• The FDA refused to review Moderna’s flu shot.

• ICON opened an accounting probe and withdrew its 2025 guidance.

• BridgeBio’s achondroplasia pill met its phase 3 goal.

• Eli Lilly bet up to $2.4bn on in vivo CAR-T.

• Isomorphic Labs new drug engine goes “well beyond AlphaFold 3”.

Browse by day:

• Weekend catch-up: Roche’s MS drug · Lilly-Innovent

• Monday: Lilly-Orna · Novo v Hims · REGENXBIO · DSM-Firmenich · Takeda-Iambic

• Tuesday: Moderna-FDA · AstraZeneca results · CSL · Isomorphic

• Wednesday: Madrigal-Ribo · Keytruda in ovarian cancer

• Thursday: Sanofi CEO · BridgeBio · EU coalition · ICON · US HRT warnings · PTC

• Friday: Novartis Vanrafia

Weekend catch-up

Roche’s oral BTK inhibitor fenebrutinib matched Ocrevus in primary progressive multiple sclerosis (PPMS).

In the 985-patient phase 3 FENtrepid trial, fenebrutinib met its primary endpoint of non-inferiority to Ocrevus (ocrelizumab) and cut risk of disability progression by 12% at 24 weeks. Fatal events ran at 1.4% against 0.2% on Ocrevus. Roche will submit its full phase 3 package once the relapsing-MS study FENhance 1 reads out in H1 2026.

• Fenebrutinib first in over a decade to reduce disability progression in PPMS · Roche

Eli Lilly and Innovent Biologics signed their seventh collaboration, an oncology and immunology alliance worth up to $8.9bn.

Innovent will be paid $350m upfront and is eligible for up to $8.5bn in milestones plus royalties, and will run development to phase 2 proof-of-concept in China while Lilly gets rights everywhere outside Greater China.

• Innovent announces strategic collaboration with Lilly · Innovent Biologics

Monday 9 February

Eli Lilly agreed to buy Orna Therapeutics for up to $2.4bn.

The deal takes Lilly into in vivo CAR-T, where a patient’s own cells are reprogrammed into cell therapies without being removed from the body. Orna’s lead candidate is a CD19-directed in vivo CAR-T for B-cell-driven autoimmune diseases, built on circular RNA. It is one of the largest acquisitions of an in vivo cell-therapy company to date.

• Lilly to acquire Orna Therapeutics to advance cell therapies · Eli Lilly

Novo sued Hims & Hers for patent infringement over compounded semaglutide.

Novo’s complaint accuses Hims of infringing its US patent covering semaglutide, and seeks a permanent injunction and damages. Hims had said over the weekend it would stop offering the compounded pill after the FDA signalled enforcement.

• Novo Nordisk takes legal action against Hims & Hers · Novo Nordisk

The FDA issued a complete response letter for REGENXBIO’s RGX-121, its gene therapy for Hunter syndrome.

REGENXBIO disclosed that the agency had turned down its accelerated-approval filing for the ultra-rare paediatric disease, questioning the trial’s eligibility criteria, its natural-history control and the surrogate endpoint used. The FDA set out requirements, including a new controlled study, that are hard to run in such a small population.

• REGENXBIO announces regulatory update on RGX-121 BLA for MPS II · REGENXBIO

DSM-Firmenich agreed to sell its Animal Nutrition & Health business to CVC at an enterprise value of about €2.2bn including an earn-out of up to €0.5bn.

The Swiss group expects to receive €1.2bn in value after closing, of which roughly €0.6bn is net cash, with it retaining a 20% stake in the unit, which had about €3.5bn of net sales in 2025. The sale, due to close by the end of 2026, largely completes its exit from animal nutrition to concentrate on fragrance, taste and health.

• dsm-firmenich agrees to divest Animal Nutrition & Health to CVC · DSM-Firmenich

Takeda struck a multi-year AI drug discovery deal with Iambic Therapeutics worth >$1.7bn.

Takeda gains access to Iambic’s platform, including its generative model NeuralPLexer, to advance small-molecule programmes in oncology, gastrointestinal disease and inflammation. Iambic takes upfront and technology-access payments and is eligible for milestones that could exceed $1.7bn plus royalties.

• Collaboration with Takeda to advance AI-driven drug design · Iambic Therapeutics

Tuesday 10 February

The FDA refused to review Moderna’s next-generation flu vaccine.

Moderna said the Center for Biologics Evaluation and Research (CBER) had issued a refusal-to-file letter for mRNA-1010, objecting solely to the trial’s comparator arm, a licensed standard-dose flu vaccine, which it said did not reflect the best-available standard of care. Moderna said the letter raised no safety or efficacy concern.

Moderna rejected the reasoning, noting the FDA had reviewed both phase 3 designs before the trials began and that the filing rested on two positive studies in 43,808 participants that met all primary endpoints. It has requested a Type A meeting.

• Refusal-to-file letter from FDA for investigational flu vaccine mRNA-1010 · Moderna

AstraZeneca reported 8% sales growth for 2025 and held its $80bn 2030 target.

Revenues rose 8% at CER (9% AER) to $58.7bn and core earnings per share 11% at CER to $9.16, and chief executive Pascal Soriot reaffirmed the 2030 goal, underpinned by more than 25 planned blockbusters and expansion in the US and China.

• AstraZeneca results: FY and Q4 2025 · AstraZeneca

CSL said CEO Paul McKenzie would retire and, a day later, issued a profit warning.

Company veteran Gordon Naylor, a former Seqirus president, steps in as interim with the plasma and vaccines group under investor pressure. First-half net profit came in at US$401m, down 81% at constant currency, after about US$1.1bn of impairments against CSL Seqirus and CSL Vifor assets tied to falling US vaccine demand.

• Paul McKenzie retires, Gordon Naylor appointed interim CEO · CSL

• CSL half-year results announcement · CSL

Isomorphic Labs unveiled a drug design engine it says goes well beyond AlphaFold 3.

The London-based Alphabet company said its proprietary engine roughly doubles AlphaFold 3’s accuracy on the hardest ligand-binding cases, reaching about 50% on cases with little similarity to training data, against about 23% for AlphaFold 3.

• IL Drug Design Engine unlocks new frontier beyond AlphaFold · Isomorphic Labs

Wednesday 11 February

Madrigal paid $60m upfront for six preclinical siRNA programmes from China’s Ribo, worth up to $4.4bn.

The licence gives Madrigal exclusive global rights to the MASH candidates, built on Ribo’s GalSTAR liver-targeting platform, to combine with its approved MASH drug Rezdiffra (resmetirom). Another deal to build its combination options around Rezdiffra.

• Madrigal expands MASH pipeline with agreement for six siRNA programs · Madrigal

• Ribo & Ribocure announce exclusive global licensing agreement with Madrigal · Ribo

The FDA approved Keytruda in platinum-resistant ovarian cancer, a tumour type the drug had never cracked.

Merck said the agency cleared Keytruda plus paclitaxel with or without Avastin for adults with PD-L1-positive platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer in the second or third line. The FDA cleared Agilent’s PD-L1 IHC 22C3 pharmDx as the companion diagnostic alongside it.

• Keytruda approved in PD-L1-positive platinum-resistant ovarian cancer · Merck

• PD-L1 IHC 22C3 pharmDx approved as companion diagnostic for Keytruda · Agilent

Thursday 12 February

Sanofi named a new chief executive to succeed Paul Hudson.

Sanofi has appointed Belén Garijo, chief executive of Merck KGaA since 2021 and the first woman to lead a DAX40 company, to the top job. Sanofi said Garijo would bring increased rigour to its strategy and R&D, with the growth of Dupixent under scrutiny.

• Belén Garijo to become Chief Executive Officer of Sanofi · Sanofi

BridgeBio’s infigratinib met its phase 3 goal in achondroplasia.

The oral FGFR1-3 selective tyrosine kinase inhibitor improved annualised height velocity by a mean 2.10 cm/year over placebo at week 52 in the PROPEL 3 trial in children (p<0.0001), and met its key secondary on height Z-score. BridgeBio plans US and European filings in H2 2026, setting up a challenge to BioMarin’s Voxzogo.

• Positive phase 3 topline results for oral infigratinib in achondroplasia · BridgeBio

European life sciences investors managing >€24bn launched a coalition.

Novo Holdings, Sofinnova, Forbion, Omega Funds and HealthCap were among the members founding the European Life Sciences Coalition in Brussels, alongside Invest Europe, to press for more capital to scale the region’s biotech companies.

The coalition put Europe at 7% of global life sciences venture capital against 63% for the United States and 14% for China, and noted that 66 of 67 EU biotech companies to list in the past six years chose to do so outside the EU.

• European Life Sciences Coalition launched to strengthen ecosystem · Invest Europe

ICON disclosed an accounting investigation and pulled 2025 guidance.

The CRO said a probe into revenue recognition had preliminarily found revenue in 2023 and 2024 may each have been overstated by less than 2%. It delayed its full-year results to 30 April and said it expects to report one or more material weaknesses.

• Update on timing of results and investigation into accounting practices · ICON

The FDA removed three risk statements from boxed warnings on six menopausal hormone therapy products.

The agency approved labelling changes stripping the warnings on cardiovascular disease, breast cancer and probable dementia from Prometrium, Divigel, Cenestin, Enjuvia, Estring and Bijuva, after a scientific-literature review begun in November 2025.

• FDA approves labelling changes to menopausal hormone therapy products · FDA

PTC Therapeutics withdrew its US filing for the Duchenne drug Translarna.

PTC pulled its NDA resubmission for Translarna in nonsense-mutation DMD after the FDA indicated the data were unlikely to meet its threshold of substantial evidence of effectiveness, This was its third failed attempt to secure US approval for the drug.

• PTC Therapeutics provides regulatory update on Translarna · PTC Therapeutics

Friday 13 February

Novartis said Vanrafia slowed kidney-function decline in IgA nephropathy, though its key secondary endpoint missed significance.

In the phase 3 ALIGN study, Vanrafia showed an eGFR difference over placebo of 2.39 mL/min/1.73 m² at week 136, the final analysis’s key secondary endpoint, that fell short of statistical significance (p=0.057). Vanrafia already holds accelerated US and China approval and Novartis plans to file for approval in 2026 regardless of the miss.

• Phase 3 data support slowing of kidney-function decline in nephropathy · Novartis

ALETH · OPEN ACCESS RESEARCH

aleth.co

The Aleth Briefs trace each story to its original source and show how the week unfolded.

The week in five lines:

• Novo and Lilly guided in opposite directions.

• Pfizer’s Metsera injection beat placebo by up to 12.3%.

• Bayer’s asundexian cut strokes 26%.

• The White House launched TrumpRx.

• Eikon Therapeutics and Veradermics both priced upsized IPOs

Browse by day:

• Weekend catch-up: EU CHMP · Lilly’s Pennsylvania plant · US FDA PreCheck

• Monday: Novo · Roche-SanegeneBio · Sanofi · GSK· PacBio-ILMN · PMCPA v Sanofi

• Tuesday: Pfizer-Metsera data · US funding law

• Wednesday: GSK · UK cancer plan · UK-US pharma deal · FTC-Express Scripts

• Thursday: TrumpRx · Novo-Hims · Bayer asundexian · biotech IPOs

Story of the week

A day apart, obesity’s two leaders guided in opposite directions and Novo’s shares fell 27% over the week.

On Tuesday Novo Nordisk forecast adj. 2026 sales and operating profit growth of -5% to -13% CER, citing US pricing pressure and most-favoured-nation deals. The company, which opened up weight-loss, guided to a contraction after growing sales 10% in 2025. The shares fell from $59.4 on Friday to $43.3 by end Thursday.

Then, on Wednesday, Eli Lilly forecast 2026 sales of $80-$83bn, c.25% above 2025, saying tirzepatide (Mounjaro and Zepbound) volumes more than offset the same US pricing pressure Novo had named. Its Q4 revenue rose 43% to $19.3bn.

• Novo Nordisk releases 2026 sales and operating profit outlook · Novo Nordisk

• Lilly reports fourth-quarter 2025 results and provides 2026 guidance · Eli Lilly

Weekend catch-up

Europe’s CHMP backed semaglutide as the first GLP-1 for MASH and opened a data-integrity review of Amgen’s Tavneos.

At its January meeting the Committee for Medicinal Products for Human Use (CHMP) recommended a conditional marketing authorisation for semaglutide (Kayshild) in non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate-to-advanced fibrosis, the first GLP-1 recommended for the indication in the EU.

It also backed Sanofi’s belumosudil (Rezurock) in chronic graft-versus-host disease after re-examination, and referred Amgen’s Tavneos over data integrity questions.

• CHMP meeting highlights, 26-29 January 2026 · European Medicines Agency

Eli Lilly will spend more than $3.5bn on a Pennsylvania plant to make retatrutide and other obesity drugs.

The Lehigh Valley site is the fourth and last of the US factories Lilly promised under its “Lilly in America” programme, and commits capacity to retatrutide, its triple GIP/GLP-1/glucagon agonist, before the drug is approved.

• Lilly selects Pennsylvania for its newest injectable medicine · Eli Lilly

The FDA opened its PreCheck pilot to drugmakers building new US manufacturing plants.

The scheme offers earlier engagement and a more predictable review for companies building domestic facilities, part of the onshoring push behind a 2025 executive order.

• FDA launches PreCheck pilot program · FDA

Monday 2 February

Novo Nordisk’s CagriSema beat semaglutide in a phase 3 type 2 diabetes trial.

In the 2,728-patient phase 3 REIMAGINE 2 trial, CagriSema (cagrilintide and semaglutide) cut HbA1c by 1.91 percentage points and weight by 14.2% at 68 weeks in patients remaining on treatment, against 1.76 points and 10.2% for semaglutide.

• CagriSema superior HbA1c reduction & weight loss in REIMAGINE 2 · Novo Nordisk

Roche paid $200m upfront for global rights to a SanegeneBio RNAi programme.

Genentech takes the licence, worth up to $1.7bn with milestones and tiered royalties, extending Roche’s return to RNA interference after years out of the field. SanegeneBio runs early development before Genentech leads the clinical development.

• SanegeneBio announces RNAi licensing collaboration with Genentech · SanegeneBio

Sanofi’s venglustat passed a phase 3 trial in Gauchers but failed in Fabry disease.

In the LEAP2MONO study, the oral glucosylceramide synthase inhibitor beat enzyme replacement therapy on neurological measures in type 3 Gaucher, whose neurological manifestations have no approved treatment, and Sanofi will file globally. In the PERIDOT study in Fabry, it missed the patient-reported primary endpoint.

Venglustat met all primary endpoints in a phase 3 type 3 Gaucher disease study · Sanofi

GSK handed back rights to Wave’s RNA-editing drug for AATD.

Wave regains WVE-006, one of the first RNA-editing candidates to reach patients, and will fund it alone while it asks the FDA about potential accelerated-approval, with feedback expected in mid-2026. Data from the RestorAATion-2 cohort is due in Q1.

• Wave announces plans to accelerate regulatory path · Wave Life Sciences

Pacific Biosciences sold its short-read sequencing assets to Illumina for $48m.

PacBio built the short-read line through its Omniome buy but paused it last year to concentrate on long reads. The sale, completed on 30 January, hands the market leader another short-read asset and eliminates a potential competitor.

• PacBio completes sale of short-read sequencing assets · Pacific Biosciences

The UK PMCPA ruled Sanofi breached industry code over Pfizer RSV claims.

The Prescription Medicines Code of Practice Authority found Sanofi’s claim that its antibody Beyfortus was more effective than Pfizer’s RSV vaccine Abrysvo was unsubstantiated, and that comments amounted to advertising a prescription medicine.

• Case ruled in breach of Clause 2 · PMCPA

Tuesday 3 February

Pfizer’s obesity injection from its Metsera deal beat placebo by 12.3%.

In the ongoing 64-week VESPER-3 phase 2b maintenance study, the ultra-long-acting GLP-1 MET-097i produced placebo-adjusted weight loss of 10% and 12.3% at week 28 in patients remaining on treatment on the two doses that will go into phase 3. It is the first real read on the $10bn Metsera acquisition.

• Pfizer’s ultra-long-acting injectable GLP-1 RA shows robust weight loss · Pfizer

Trump signed a $1.2tn spending law that ended the federal shutdown.

The Act carries drug provisions the industry has been tracking: a revived rare paediatric disease priority-review voucher programme, reauthorised to 2029, and new Medicare pharmacy-benefit-manager transparency rules. The House passed it 217-214.

• H.R. 7148, the Consolidated Appropriations Act, 2026, signed · The White House

Wednesday 4 February

GSK guided to slower growth in 2026 in Luke Miels’ first outlook as CEO.

Turnover is forecast up 3-5% this year, down on 2025, while GSK held to its target of sales above £40bn by 2031 as its top-selling HIV drugs approach patent expiry. Miels used his first results as CEO to press a more product-focused, launch-led strategy.

• FY 2025 results announcement · GSK

England set out a national cancer plan targeting 75% five-year survival.

The National Cancer Plan for England commits to three in four people diagnosed from 2035 surviving at least five years, which the government puts at about 320,000 additional lives, on the back of earlier diagnosis and faster treatment. It pledges £2.3bn for 9.5 million more diagnostic tests in community centres open 12 hours/day.

• National Cancer Plan for England · Department of Health and Social Care

The UK’s pharma trade deal with the US will cost the Department of Health and Social Care (DHSC) about £1bn over the current Spending Review period.

In a letter to the Commons Science, Innovation and Technology Committee, Lord Vallance said the cost will be funded through allocations made to DHSC at the Spending Review, with front-line services protected. DHSC/NHS/NICE ran the analysis.

• Cost of UK-US pharma deal will be met by DHSC, minister confirms · SIT Committee

The FTC accepted Express Scripts consent agreement to settle insulin-price case.

Under the proposed order, Express Scripts would stop favouring high-list-price drugs where cheaper equivalents exist and would delink its pay from the rebates it negotiates. Changes the FTC estimates would cut patients’ out-of-pocket costs by up to $7bn over ten years. The case accused the largest PBM of inflating insulin list prices.

• Caremark Rx, Zinc Health Services, et al., In the Matter of (Insulin) · FTC

Thursday 5 February

The White House launched TrumpRx, its direct-to-consumer drug site.

President Trump unveiled TrumpRx.gov, listing about 40 medicines at the cash prices manufacturers agreed under his most-favoured-nation deals. The site does not sell drugs but routes patients to each company’s own platform or discount coupons. How much insured patients gain is unclear, since their copays often sit below the cash price.

• Fact sheet: President Trump launches TrumpRx.gov · The White House

Hims & Hers launched a compounded semaglutide pill at $49 for the first month, and Novo Nordisk said it would take legal action.

Hims began selling a compounded semaglutide tablet at $49 for the first month of a five-month plan, with the remaining months at $99, undercutting the branded oral Wegovy. Hims says the product uses a different formulation and delivery system. Novo called it an unapproved “knockoff” and said that it will take legal action.

• H & H expands weight loss portfolio with compounded semaglutide · Hims & Hers

• Novo Nordisk’s statement on the Hims compounded pill · Novo Nordisk

Bayer’s asundexian cut recurrent strokes by 26% in phase 3.

In the >12,300-patient OCEANIC-STROKE trial the oral Factor XIa inhibitor asundexian reduced ischaemic stroke by 26% after a non-cardioembolic stroke or high-risk transient ischaemic attack, with no rise in major bleeding versus placebo. Bayer described it as the first phase 3 of a Factor XIa inhibitor to be completed successfully.

• Asundexian after a non-cardioembolic ischaemic stroke · Bayer

Eikon Therapeutics and Veradermics both priced upsized IPOs.

Eikon, led by Merck & Co veterans and built around super-resolution microscopy, priced 21.18m shares at $18 to list on Nasdaq, for gross proceeds of c.$381m. Hair-loss specialist Veradermics priced a $256.3m NYSE IPO at $17 on 3 February.

• Eikon Therapeutics announces pricing of upsized IPO · Eikon Therapeutics

• Veradermics announces pricing of upsized IPO · Veradermics

ALETH · OPEN ACCESS RESEARCH

aleth.co

The Aleth Briefs trace each story to its original source and show how the week unfolded.

Top five stories:

• GRAIL filed Galleri for FDA approval.

• AstraZeneca committed $15bn to China.

• Roche reported 22.5% placebo-adjusted weight loss for CT-388.

• Medicare picked 15 more drugs for price talks.

• FDA lifted Intellia’s phase 3 CRISPR trial hold.

Browse by day:

• Weekend: NHS cancer · Guardant injunction · Merck/Revolution talks end

• Monday: UK biotech IPOs · AZ Cambridge · Genmab halt · Elevidys follow-up

• Tuesday: Roche obesity · Waters/BD · Intellia lift · EU/India deal · Medicare · J&J

• Wednesday: Lilly/Seamless · REGENXBIO · Cellares · Danaher · newborns · Yuvezzi

• Thursday: AZ China · Roche · Thermo Fisher · mRNA flu · Galleri · Repertoire/Lilly

• Friday: AstraZeneca/CSPC deal

Weekend catch-up

NHS England launched a national register for people carrying inherited variants that increase cancer risk.

The register covers >100 genes and gives the NHS a route to monitor and recall people for tests.

• Inherited cancer checks programme · NHS England

Patent Court rejects Guardant’s injunction request against Sophia Genetics.

The Paris Local Division refused provisional measures over Sophia’s liquid-biopsy test. It found two patents more likely than not invalid for added matter and said infringement of the third had not been shown with sufficient certainty.

• Final Order, Guardant Health v. Sophia · Unified Patent Court

Merck was no longer in talks to buy Revolution Medicines, The Wall Street Journal reported.

• Merck No Longer in Talks to Buy Revolution · The Wall Street Journal

Monday 26 January

UK drug developers considering IPOs after a four-year domestic biotech drought.

The BioIndustry Association (BIA) told Fierce Biotech that companies were looking at Nasdaq. Baker McKenzie lawyers expected at least two possible London biotech listings in 2026.

• ‘Things are looking up’: British biotechs · Fierce Biotech

AstraZeneca kept its planned £200m Cambridge expansion on hold.

The company said its planning application preserved the option to build rather than restarting the project. The proposed site would employ about 1,000 people.

• AstraZeneca keeps UK research site · Fierce Biotech

Genmab stopped trial enrolment of cancer candidate acquired in $1.8bn ProfoundBio acquisition.

Endpoints reported that the halt affected an early-stage programme. Genmab bought ProfoundBio in 2024 to acquire its antibody-drug conjugate pipeline.

• Genmab halts enrollment · Endpoints

Sarepta said three-year data showed Elevidys slowed the loss of motor function in ambulatory Duchenne patients.

Elevidys (delandistrogene moxeparvovec) produced at least 70% less decline than a propensity-weighted external control on time to rise and the 10-metre walk or run. The follow-up covered 52 patients from EMBARK.

• Sarepta Announces Positive Topline Results · Sarepta

Tuesday 27 January

Roche’s CT-388 produced 22.5% placebo-adjusted weight loss.

The highest once-weekly dose had not reached a weight-loss plateau at 48 weeks. Some 54% of recipients ended below the obesity threshold, against 13% on placebo, and Roche said phase 3 was expected to begin in Q1.

• Roche announces positive Phase II results · Roche

Waters shareholders approved the combination with BD’s Biosciences.

99% of shares represented at the meeting voted in favour. Waters said regulatory approvals were in place and expected the transaction to close on 9 February.

• Shareholders approve combination with BD’s Biosciences · Waters

The FDA lifted the hold on Intellia’s phase 3 MAGNITUDE-2 CRISPR trial.

The decision restarts enrolment of patients with hereditary transthyretin amyloidosis with polyneuropathy. The MAGNITUDE cardiomyopathy trial remained paused.

• Lift of FDA hold on MAGNITUDE-2 Ph3 trial in ATTRv-PN · Intellia

The EU and India concluded negotiations on a free-trade agreement.

Once signed, ratified and in force, the agreement would eliminate or reduce tariffs on >96% of EU goods exports into India, including 11% tariffs on pharmaceuticals.

• EU and India conclude landmark Free Trade Agreement · European Commission

CMS selected 15 medicines for the third Medicare price-negotiation cycle.

The round includes Part B medicines for the first time. Negotiations run through 2026 and the resulting prices take effect on 1 January 2028.

• 15 drugs selected for third Medicare price-negotiation cycle · CMS

The FDA approved J&J’s Darzalex Faspro quadruplet for multiple myeloma.

Darzalex Faspro (daratumumab and hyaluronidase) can now be combined with bortezomib, lenalidomide and dexamethasone in adults ineligible for an autologous stem-cell transplant.

• DARZALEX FASPRO quadruplet approved for transplant-ineligible myeloma · J&J

Wednesday 28 January

Eli Lilly signed a hearing-loss gene-editing deal with Seamless Therapeutics.

Seamless will design programmable recombinases that can make large, precise DNA changes without relying on the cell’s repair machinery. Lilly receives rights to develop the resulting therapies. Potential payments exceed $1.1bn.

• Lilly collaboration · Seamless Therapeutics

The FDA placed two REGENXBIO gene therapies on clinical hold after a brain tumour was found in a treated child.

The five-year-old had received RGX-111 four years earlier. Preliminary analysis found AAV integration associated with PLAG1 overexpression. RGX-121 was also held because the programmes share relevant risks.

• Regulatory update on ultra-rare MPS programmes · REGENXBIO

Cellares raised $257m to expand automated cell-therapy manufacturing.

BlackRock and Eclipse co-led the Series D, taking total capital raised to $612m. Cellares expects clinical manufacturing in H1 2026 and commercial-scale in 2027.

• $257m Series D led by BlackRock and Eclipse · Cellares

Danaher’s Q4 revenue rose 4.5% to $6.8bn.

Full-year revenue increased 3% to $24.6bn. The life-science tools group guided to 3% to 6% core revenue growth for 2026.

• Q4 and full-year 2025 results · Danaher

An NIH-funded study selected seven programmes to assess integration of whole genome sequencing into public health newborn screening.

BEACONS chose Iowa, Minnesota, New York, Oregon, Puerto Rico, South Carolina and Texas. Its gene list targets conditions that can be acted on during a child’s first year.

• Seven sites and final gene list for genomic newborn screening · Ariadne Labs

The FDA approved Tenpoint’s combination eye drop Yuvezzi for presbyopia.

Yuvezzi (carbachol and brimonidine) combines two existing agents in a formulation for adults with blurry close-up vision due to age. Tenpoint plans a Q2 US launch.

• FDA approval of YUVEZZI, 1st combo presbyopia eye drop · Tenpoint Therapeutics

Thursday 29 January

AstraZeneca committed $15bn to China through 2030.

The investment covers research and manufacturing, including cell therapy and radioconjugates. AstraZeneca said it would expand its existing R&D centres in Beijing and Shanghai and increase its Chinese workforce beyond 20,000.

• AstraZeneca invests $15bn in China through 2030 · AstraZeneca

Roche reported 2025 sales growth of 7%

Sales reached CHF 61.5bn +7% CER, or 2% in CHF. Roche forecast mid-single-digit sales growth at constant currencies for 2026.

• 2025 results: sales up 7% · Roche

Thermo Fisher Scientific’s 2025 revenue rose 4% to $44.6bn.

Q4 revenue increased 7% to $12.2bn. Adjusted earnings per share rose 5% for the year. Thermo guided 2026 revenue of $46.0-$47.2bn, representing growth of 4%-6%.

• Q4 and full-year 2025 results · Thermo Fisher

• TMO Q4 2025 earnings call transcript · The Motley Fool

Sanofi deprioritised its next-generation mRNA seasonal flu vaccine programme, Fierce Biotech reported.

Sanofi said it did not anticipate a near-term launch. Its existing protein-based influenza portfolio remains in development and on the market.

• Sanofi scraps attempt to develop mRNA seasonal flu vaccine · Fierce Biotech

GRAIL submitted Galleri for FDA premarket approval.

The final module completes the application for its multi-cancer early-detection (MCED) blood test. The filing draws on PATHFINDER 2 and the NHS-Galleri trial.

• FDA PMA application for the Galleri multi-cancer early detection test · GRAIL

Repertoire and Eli Lilly signed an autoimmune collaboration worth up to $1.9bn plus royalties.

Repertoire receives $85m upfront and up to $1.84bn in milestones. It will use its DECODE platform to nominate tolerising therapies before Lilly takes over clinical development and commercialisation.

• Lilly collaboration on tolerizing therapies for autoimmune diseases · Repertoire

Friday 30 January

AstraZeneca agreed to pay CSPC $1.2bn upfront for eight long-acting obesity and diabetes programmes.

AstraZeneca would receive ex-China rights to the portfolio, led by once-monthly GLP-1/GIP candidate SYH2082. Closing was expected in Q2. CSPC can receive up to $3.5bn in development and regulatory milestones, plus sales payments and royalties.

• AstraZeneca agrees obesity and T2D deal with CSPC · AstraZeneca

ALETH · OPEN ACCESS RESEARCH

aleth.co

The Aleth Briefs trace each story to its original source and show how the week unfolded.

The week in five lines

• The US Supreme Court agreed to hear key Hikma v. Amarin case.

• GSK agreed to buy RAPT for an estimated $2.2bn.

• AstraZeneca will quit Nasdaq for the NYSE.

• Moderna pulled back from vaccine trials.

• J&J guided 2026 revenue to $100bn.

In this edition

• Weekend catch-up: SCOTUS skinny label; Cordis sale; biotech IPOs

• Monday: Europe pricing push; Valneva withdrawal

• Tuesday: GSK-RAPT deal; ViiV reshuffle; AZ NYSE; melanoma vaccine; Qiagen strategic review

• Wednesday: J&J $100bn; OpenEvidence raise; IntraBio approval

• Thursday: Abbott miss; Corcept ovarian win; Moderna vaccine retreat; Corxel raise; US-WHO exit

• Friday: Sanofi eczema

Weekend catch-up

The US Supreme Court agreed to hear Hikma’s challenge to Amarin over a generic’s “skinny label”.

The court granted certiorari on Friday in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. (No. 24-889), taking up the Federal Circuit ruling that let Amarin’s induced-infringement claim proceed even though Hikma had carved the patented cardiovascular indication out of its generic Vascepa (icosapent ethyl) label. This case impacts branded drugs with secondary uses still under patent and could set how far generics can carve a patented use out of their labelling.

• Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889 - Supreme Court of the United States, docket entry of 16 January 2026

Hellman & Friedman is exploring the sale of med-device maker Cordis at >$9bn, Bloomberg reported.

The PE firm is working with advisers to gauge interest, with about half a dozen listed medtech companies weighing bids, according to the report; talks are early and no sale is assured. H&F bought Cordis, which makes stents and other cardiovascular devices, from Cardinal Health in 2021 for about $1bn.

• H&F Explores $9 Billion-Plus Sale of Medical Device Maker Cordis - Bloomberg

SpyGlass Pharma and Agomab Therapeutics filed Nasdaq IPOs

SpyGlass is an eye-disease company, whose lead asset is a drug-eluting intraocular lens in phase 3 for glaucoma. It filed its S-1 on Friday to trade under the ticker SGP. Immunology developer Agomab Therapeutics filed for its own Nasdaq listing in the same window. Only a handful of drug developers completed sizeable IPOs in 2025, and several 2026 biotech IPOs are taking shape a week after the JPM conference.

• SpyGlass Pharma, Inc. Form S-1

• Agomab Therapeutics NV Form F-1

Monday 19 January

US drugmakers are pressing European governments to accept higher prices

The push follows the MFN pricing deals US companies struck with the Trump administration, which they say force them to raise prices abroad to defend the $700bn US market. Pfizer chief executive Albert Bourla, the first to sign such a deal, told reporters at the JPM conference that faced with cutting the US price to France’s level or pulling out, the company would stop supplying France.

• Financial Times report, 19 January 2026 - Financial Times

Valneva withdrew its chikungunya vaccine after the FDA suspended the shot.

Valneva voluntarily withdrew the US BLA and IND application for Ixchiq, after the FDA suspended the licence in August 2025 following four new reports of serious adverse events; earlier safety concerns had centred mainly on older recipients. The agency has now also placed the IND on clinical hold to investigate a newly reported serious event in a younger adult. This was Valneva’s main commercial launch it its largest market.

• Valneva Provides Update on Chikungunya Vaccine IXCHIQ

• Valneva Announces FDA’s Decision to Suspend License of IXCHIQ In the U.S.

Tuesday 20 January

GSK agreed to buy US biotech RAPT Therapeutics for $2.2bn, its first major deal under new chief executive Luke Miels.

GSK will pay $58 a share in cash, an equity value of $2.2bn and about $1.9bn net of cash, for RAPT’s ozureprubart, a long-acting anti-IgE antibody in phase 2b for the prevention of food-allergy reactions. Its once-quarterly dosing would set it apart from Novartis and Roche’s Xolair (omalizumab), which dominates the anti-IgE class.

GSK enters agreement to acquire RAPT Therapeutics

Pfizer agreed to exit the HIV joint venture ViiV Healthcare as Shionogi committed $2.1bn to raise its holding.

GSK, Pfizer and Shionogi agreed to replace Pfizer’s 11.7% interest in ViiV with new shares issued to Shionogi. Pfizer receives $1.875bn and GSK a $250m special dividend, leaving GSK with 78.3% and Shionogi 21.7%. Pfizer, which warned in December that 2026 revenue will fall, exits a business it helped found while Shionogi doubles down.

• GSK, Pfizer and Shionogi agree on changes to ViiV Healthcare shareholding

AstraZeneca will delist from Nasdaq and move its US listing to the NYSE.

AZ gave notice that it will withdraw its ADSs and debt from Nasdaq, effective after the close on 30 January, with its ordinary shares and debt starting to trade directly on the NYSE from 2 February. This will complete a shareholder-approved plan to harmonise its listing across London, Nasdaq Stockholm and New York.

• AstraZeneca to complete direct listing of shares and US debt securities on NYSE

Moderna and Merck’s personalised cancer vaccine sustained a 49% cut in the risk of melanoma recurrence or death at five years when added to Keytruda.

In the phase 2b KEYNOTE-942 trial, intismeran autogene (mRNA-4157) plus Keytruda reduced recurrence or death by 49% (hazard ratio 0.510) against Keytruda alone in resected high-risk stage III/IV melanoma, matching the benefit seen at three years.

• Moderna & Merck announce 5-yr data for intismeran autogene in melanoma

Qiagen is weighing strategic options, including sale, Bloomberg reported.

The molecular-testing company is working with advisers and has held talks with several possible buyers, including some US strategics, according to the report; its shares rose about 12%. A 2020 Thermo Fisher approach worth roughly $12bn collapsed after an activist opposed it, and the pending exit of chief executive Thierry Bernard is seen as clearing the way.

• Qiagen Is Said to Consider Strategic Options Amid Fresh Interest - Bloomberg

Wednesday 21 January

J&J guided to 2026 revenue of $100bn to $101bn, led by Darzalex.

FY2025 sales rose 6.0% to $94.2bn and Q4 sales 9.1% to $24.6bn. Darzalex, its multiple myeloma antibody, delivered $14.4bn in 2025, with $3.9bn in Q4. J&J said pharma sales topped $60bn for the first time and forecast double-digit growth by 2030.

• Johnson & Johnson reports Q4 and Full-Year 2025 results

Health-AI company OpenEvidence raised $250m, doubling its valuation to $12bn.

The Series D, co-led by Thrive Capital and DST Global, roughly doubled the valuation of three months earlier and takes total funding to c.$700m. OpenEvidence’s clinical-search tool, used widely by US physicians, joins the wave of capital chasing medical AI.

• OpenEvidence Raises $250 Million to Build Medical Superintelligence for Doctors

IntraBio won European approval for Aqneursa in Niemann-Pick type C and a phase 3 win in ataxia-telangiectasia.

The European Commission cleared Aqneursa for the neurological signs of Niemann-Pick type C in patients aged six and over weighing at least 20 kg. Separately, a phase 3 crossover trial in ataxia-telangiectasia, a rare neurodegenerative disease with no approved treatment, showed a statistically significant improvement on the SARA ataxia scale. IntraBio said it would advance regulatory submissions.

• IntraBio Receives EC Approval of AQNEURSA for Niemann-Pick Type C Disease

• IntraBio Announces Positive Pivotal Trial Results of Levacetylleucine for the Treatment of Ataxia-Telangiectasia

The FDA set out draft guidance on using minimal residual disease and complete response to support accelerated approval in multiple myeloma.

The draft recommends MRD negativity in the bone marrow, measured by flow cytometry or next-generation sequencing, and complete response as primary endpoints to support accelerated approval, with clinical benefit confirmed later on survival or progression. Because response rates in myeloma are now so high, traditional endpoints can no longer adequately differentiate between new therapies.

• Minimal Residual Disease and Complete Response in Multiple Myeloma: Use as Endpoints To Support Accelerated Approval - Federal Register

Thursday 22 January

Abbott’s Q4 sales were light and its shares fell sharply.

Q4 sales rose 4.4% to $11.46bn against a consensus of about $11.8bn, as nutrition fell 8.9% and diagnostics slipped 3.6% organically on China’s volume-based procurement. Devices grew 12.3% and pharma 7.0% organically. It guided to 2026 organic sales growth of 6.5-7.5%. Shares fell around 10% on the day.

• Abbott Reports Q4 and Full-Year 2025 Results; Issues 2026 Financial Outlook

Corcept’s relacorilant improved overall survival in a phase 3 ovarian cancer trial.

In the ROSELLA trial, relacorilant plus nab-paclitaxel cut the risk of death by 35% (hazard ratio 0.65, p=0.0004) against nab-paclitaxel alone in platinum-resistant ovarian cancer, with median survival of 16.0 months versus 11.9. The win follows the FDA’s rejection of relacorilant in Cushing’s syndrome; the agency has set a decision on the ovarian filing for 11 July, and Corcept has filed in Europe.

• Overall Survival Primary Endpoint Met in Corcept’s Pivotal Phase 3 ROSELLA Trial of Relacorilant in Patients with Platinum-Resistant Ovarian Cancer

Moderna will not fund new late-stage vaccine trials blaming US hostility.

Speaking to Bloomberg TV at Davos, Bancel said regulatory delays and shrinking official support had made the market too small: “You cannot make a return on investment if you don’t have access to the U.S. market.“ This retreat pulls late-stage funding from the core technology Moderna was built on, as U.S. vaccine policy undergoes a major overhaul under Health Secretary Robert F. Kennedy Jr.

• Moderna Curbs Investment in Vaccine Trials Due to US Backlash - Bloomberg

China-founded Corxel raised $287m to push an oral GLP-1 pill beyond China.

The Series D1, led by RTW Investments and SR One, funds an ongoing US phase 2 in obesity, a planned global phase 2 in type 2 diabetes and phase 3 preparations for CX11, an oral small-molecule GLP-1 receptor agonist Corxel licensed ex-China from Vincentage. It is one of the larger private rounds for an oral incretin as Eli Lilly, Novo Nordisk and several biotechs race into the pill market.

• CORXEL Announces $287 million Series D1 Financing

The United States formally left the World Health Organization.

The exit took effect on Thursday, a year after President Trump ordered it by executive order on his first day back in office and the required 12 months’ notice ran out. Critics warn the departure damages US and global health.

• Fact Sheet: U.S. Withdrawal from the World Health Organization - HHS

• Withdrawing the US From the World Health Organization - The White House

Friday 23 January

Sanofi will file eczema drug amlitelimab despite a mixed set of phase 3 readouts.

The SHORE study met all primary and key secondary endpoints in moderate-to-severe atopic dermatitis, but COAST 2 was mixed: it hit the US co-primary endpoint while missing statistical significance on its EU co-primaries. Sanofi, which has tipped the OX40-ligand antibody as an immunology blockbuster to follow Dupixent (dupilumab), said it will proceed with global submissions in H2 2026.

• Press Release: Sanofi’s amlitelimab confirms its potential in atopic dermatitis

ALETH · OPEN ACCESS RESEARCH

aleth.co

The Aleth Briefs trace each story to its original source and show how the week unfolded.

The week in five lines

• Execs at JPM Healthcare conference see biopharma mega-mergers in 2026

• Boston Scientific agreed to buy Penumbra at a $14.5bn enterprise value.

• Trump asked Congress to codify US drug-price deals.

• AbbVie signed a US pricing deal and pledged $100bn.

• EQT approached UK’s Oxford Biomedica for a buyout.

In this edition

• Weekend catch-up: JPM deals outlook

• Tuesday: GLP-1 suicide warnings; Novo deal hunt; Menkes approval; US probe

• Wednesday: UK OXB approach; Tecvayli phase 3; Jazz voucher sale

• Thursday: US pricing; Boston Scientific-Penumbra; Novo grant; NICE NHS prices

Weekend catch-up

Healthcare dealmakers arrived at the J.P. Morgan conference betting on a “new wave of mega-mergers in 2026”.

Bankers and executives gathering in San Francisco on Friday expected 2026 tie-ups to rival the peaks of 2019 and 2021, when deal values approached half a trillion dollars, after a thin 2024 and a partial 2025 rebound. More forgiving antitrust scrutiny under the Trump administration has given companies confidence to weigh acquisitions of $30bn or more. Jeremy Meilman, JP Morgan’s global co-head of healthcare banking, said deals “get approved... that could have had more regulatory risk in the past“, and a JP Morgan survey found 60% expecting biotech M&A to accelerate.

• US healthcare dealmakers hope for megamergers in 2026 - Reuters (RTÉ)

Monday 12 January

Abivax shares jumped 32% on report Lilly was weighing a EUR15bn takeover.

La Lettre reported Lilly was working towards a EUR15bn bid for the Paris-based biotech, whose obefazimod cleared a phase 3 trial in ulcerative colitis, and was seeking guidance if France’s foreign-investment screening would apply. France’s economy and finance ministry said it had received no formal request for approval and had had no contact with Lilly. Any acquisition of a strategic pharmaceutical company would fall under its screening regime. Neither company confirmed an approach.

• Ready to put €15 billion on the table for biotech firm Abivax - La Lettre

• Eli Lilly-Abivax rumour stirs markets, but no formal steps confirmed - Euro Biotech

AbbVie struck a drug-pricing deal with the US administration and pledged $100bn of US investment over ten years in exchange for tariff relief.

The company agreed to cut prices on certain Medicaid medicines and to sell Humira and other products direct to patients through TrumpRx, in return for exemption from branded-pharmaceutical import tariffs. It committed $100bn to US research, development and manufacturing over the next decade. Chairman and chief executive Robert Michael said the agreement let the company “move beyond policies that harm American innovation“. AbbVie was among the last of the large drugmakers to settle.

• AbbVie and Trump Administration Reach Agreement to Improve Access and Affordability for Americans

AbbVie paid $650m upfront to license RemeGen’s PD-1/VEGF bispecific

The deal for RC148, worth up to about $5.6bn with milestones and tiered royalties, gives AbbVie rights outside Greater China to a clinical-stage bispecific for solid tumours including non-small cell lung and colorectal cancer. It is the latest large upfront Western for a Chinese-originated asset in the PD-1/VEGF class.

• AbbVie and RemeGen Announce Exclusive Licensing Agreement for a Novel Bispecific Antibody for Advanced Solid Tumors

Eli Lilly and Nvidia will build a $1bn AI drug-discovery lab in the Bay Area.

The co-innovation lab puts Lilly’s biologists alongside Nvidia’s model builders and runs on Nvidia’s BioNeMo software and Vera Rubin hardware. Its work is expected to begin in South San Francisco early this year. Unusually, the deal embeds a chipmaker inside drug discovery rather than merely selling compute into it.

• NVIDIA & Lilly Announce AI Lab to Reinvent Drug Discovery in Age of AI

The FDA rejected Atara and Pierre Fabre’s cell therapy Ebvallo a second time.

Announced on Monday, the complete response letter said the single-arm ALLELE trial the FDA had previously accepted is “no longer... adequate“ to support accelerated approval, citing confounded interpretability. Atara called it a “complete reversal of position“ by the FDA. Ebvallo (tabelecleucel) is already approved in Europe.

• Atara Biotherapeutics Provides Regulatory and Business Update on Ebvallo

Pharma leaders at JPM urged Washington to out-compete China on biotech not try to block its rise.

With a run of deals for Chinese-originated drugs framing the week, executives cast China’s advance as a “Sputnik moment“ and pressed for faster, cheaper US clinical development. John Maraganore said “innovation should come from anywhere in the world“ and warned against letting biotech “become like semiconductors“.

• JPM26: US biotech’s ‘Sputnik moment,’ - BioPharma Dive

Tuesday 13 January

The FDA asked drugmakers to strip the suicidal-behaviour warning from GLP-1 weight-loss drugs after a review found no increased risk.

The request covers Novo Nordisk’s Wegovy (semaglutide) and Saxenda (liraglutide) and Eli Lilly’s Zepbound (tirzepatide), removing a warning that has sat on the class since its move into obesity. The FDA’s review of 91 trials with 107,910 patients found no evidence of raised risk of suicidal thoughts, confirming a preliminary 2024 finding.

• FDA Requests Removal of Suicidal Behavior and Ideation Warning from GLP-1 Receptor Agonist Medications

Novo Nordisk said it was back in the market for obesity deals of any size, months after losing Metsera to Pfizer.

Chief executive Mike Doustdar told Bloomberg at the JPM conference that Novo was “in the market for big or small“ obesity deals and ready to go “very big“, as it works to rebuild an obesity pipeline after being outbid for Metsera last year.

• Novo’s CEO is ready to go ‘very big’ in hunt for obesity deals - Bloomberg

The FDA approved Sentynl’s Zycubo as the first treatment for Menkes disease, a rare and usually fatal copper-metabolism disorder in children.

The approval covers Zycubo (copper histidinate), a subcutaneous copper injection developed with Cyprium Therapeutics that bypasses the defective intestinal absorption caused by ATP7A mutations. In pooled single-arm data, early treatment cut the risk of death by nearly 80% against an untreated contemporaneous external-control cohort. The FDA had rejected the same application under four months earlier.

• Sentynl Therapeutics Announces FDA Approval of Zycubo (copper histidinate)

The Trump administration appears to have quietly closed its national-security investigation into pharmaceutical imports, according to Endpoints News.

Endpoints reported on Tuesday that the Commerce Department appeared to have concluded its Section 232 probe, leaving the president 90 days to decide on any action, which could include tariffs, and a further 15 days to act.

• Exclusive: Trump administration appears to have ended its US trade probe into pharma - Endpoints News

Wednesday 14 January

Oxford Biomedica confirmed an unsolicited takeover approach from private equity group EQT, having rejected earlier proposals as too low.

The UK-listed cell and gene therapy manufacturer said that EQT’s approach concerning a possible cash offer followed earlier proposals the board had turned down as undervaluing the business. Under the takeover code EQT has until 5pm on 11 February to announce a firm intention to bid or walk away. This adds Oxford Biomedica to a run of private equity interest in London-listed companies.

• Response to press speculation - Oxford Biomedica

J&J bispecific Tecvayli cut the risk of progression or death by 71% as a single agent in earlier-line multiple myeloma.

At the first pre-specified interim analysis of the phase 3 MajesTEC-9 trial, Tecvayli (teclistamab) monotherapy also reduced the risk of death by 40% against standard care in patients who had received one to three prior lines of therapy and were predominantly refractory to anti-CD38 therapy and Revlimid (lenalidomide). It is the second phase 3 win supporting a move of the drug out of late-line myeloma.

• Tecvayli monotherapy demonstrates superior progression-free and overall survival as early as first relapse in multiple myeloma - Johnson & Johnson

Jazz Pharmaceuticals agreed to sell a priority review voucher for $200m, the highest price in a decade.

CEO Renee Gala disclosed the agreement at the JPM conference without naming the buyer. Voucher prices have been rising and a figure of $200m is a new benchmark. Jazz earned the voucher on the FDA’s August approval of brain-tumour drug Modeyso.

• JPM26: Jazz inks $200M priority review voucher sale - Fierce Pharma

Thursday 15 January

Trump unveiled “The Great Healthcare Plan” and asked Congress to write his most-favoured-nation drug-pricing deals into law.

The four-part framework pairs the pricing codification with a shift of insurance subsidies into direct payments to consumers, an end to pharmacy-benefit-manager kickbacks and new price-transparency rules. Codifying the company-by-company deals would turn a set of executive-branch arrangements into a standing obligation that a later administration could not simply drop.

• The Great Healthcare Plan - The White House

Boston Scientific agreed to buy clot-removal specialist Penumbra at an enterprise value of about $14.5bn, its second acquisition of the week.

The cash-and-stock deal values Penumbra at $374 a share, paid roughly 73% in cash and 27% in stock, with Boston Scientific funding the about $11bn cash portion from cash and new debt. Penumbra’s mechanical thrombectomy devices pull blood clots from veins and arteries. It follows Boston Scientific’s purchase of Valencia Technologies days earlier and ranks as the period’s largest single transaction.

• Boston Scientific announces agreement to acquire Penumbra, Inc.

The Novo Nordisk Foundation committed up to DKK5.5bn, about EUR736m, to its BioInnovation Institute through 2035.

The ten-year grant announced during JPM week funds the Copenhagen incubator to back more start-ups and widen into fields including AI and quantum technology. The institute has helped create more than 130 companies since 2018 and is one of the largest private initiatives responding to Europe’s early-stage funding gap.

Novo Nordisk Foundation grants DKK5.5bn to elevate innovation in Denmark & Europe

The new chief executive of NICE said NHS drug prices should not rise for years, resisting the US pressure now heading to Congress.

The FT reported that NICE’s new chief said giving in to US demands for higher UK payments would be a backward step for the health system, putting the UK’s cost-effectiveness gatekeeper directly against the pricing efforts underway in Washington.

• NICE chief opposes higher NHS medicine prices - Financial Times

ALETH · OPEN ACCESS RESEARCH

aleth.co

The Aleth Briefs trace each story to its original source and show how the week unfolded.

The week in five lines

• Merck was reportedly in $32bn talks to acquire Revolution Medicines.

• GSK and Ionis reported a hepatitis B functional cure.

• Novo Nordisk launched its Wegovy pill at $149 a month.

• The CDC cut universal childhood vaccine recommendations to 11 diseases.

• Amgen bought UK biotech Dark Blue for up to $840m.

In this edition

• Monday: Novo Wegovy pill; US childhood vaccines; NIH funding; Zenas readout

• Tuesday: Amgen Dark Blue takeover; Alumis psoriasis; STAAR rejects Alcon

• Wednesday: GSK hepatitis B; Lilly buys Ventyx

• Thursday: Merck-Revolution talks; obesity weight regain

• Friday: Aktis IPO

Monday 5 January

Novo Nordisk put its Wegovy pill on sale in the US at $149 a month.

Novo began selling Wegovy as a once-daily pill on Monday, with the 1.5 mg starting dose at $149 a month for cash-paying patients and as little as $25 a month for commercially insured patients using its savings offer. The 4 mg dose holds at $149 until 15 April, then rises to $199, while the top 9 mg and 25 mg doses cost $299. It is the first oral GLP-1 cleared for weight loss, stocked at >70,000 pharmacies including CVS and Costco and through telehealth providers Ro, LifeMD and WeightWatchers.

• Novo Nordisk’s Wegovy pill, the first and only oral GLP-1 for weight loss in adults, now broadly available across America

The CDC reorganised its childhood vaccine schedule, leaving 11 diseases universally recommended.

Acting on a presidential memorandum, the CDC split the childhood immunisation schedule Monday into three tiers: universal, for high-risk groups, or based on shared clinical decision-making. Influenza, hepatitis A, meningococcal ACWY and rotavirus left the universal tier, while Covid-19 and hepatitis B had already been narrowed in 2025. Health secretary Robert F Kennedy Jr said the schedule now more closely matches Australia, Japan and Europe, with insurance coverage unchanged.

• CDC Acts on Presidential Memo to Update Childhood Immunization Schedule

A US appeals court upheld the block on NIH cap on research overhead at 15%.

The US First Circuit Court of Appeals ruled Monday that NIH’s 15% cap on indirect-cost reimbursement violated congressional and departmental rules, affirming a lower-court injunction. Indirect costs fund the facilities, administration and core staff supporting grants, determining how much universities retain. The unanimous panel left negotiated rates in place while the case proceeds. Judge Kermit Lipez wrote that Congress had barred NIH from replacing them with a uniform rate.

• United States Court of Appeals for the First Circuit, No. 25-1343 (opinion) - US Court of Appeals for the First Circuit

Zenas BioPharma’s obexelimab hit its phase 3 goal in IgG4-related disease, but the shares fell more than half.

In the registrational INDIGO trial, obexelimab cut the risk of an IgG4-related disease flare requiring rescue therapy by 56% against placebo (hazard ratio 0.44, p=0.0005) across 194 patients over 52 weeks, and met all four key secondary endpoints with a favourable safety profile. Investors focused on an unfavourable cross-trial comparison with Amgen’s approved Uplizna (inebilizumab), and the shares fell by more than half. Zenas said obexelimab could serve as a first-line therapy.

• Zenas BioPharma Announces Positive Results from Phase 3 INDIGO Registrational Trial of Obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD)

Tuesday 6 January

Amgen acquired Oxford spinout Dark Blue Therapeutics for up to $840m, adding a preclinical leukaemia programme.

Amgen has acquired Dark Blue Therapeutics, a University of Oxford spinout, in a deal worth up to $840m (upfront not disclosed). Dark Blue’s lead molecule is a small-molecule protein degrader aimed at MLLT1 and MLLT3, two proteins that drive certain forms of acute myeloid leukaemia (AML), and is in late preclinical work. R&D head Jay Bradner said “acute myeloid leukemia remains one of the most difficult cancers to treat“. It is the latest US takeover of a British biotech.

• Amgen Acquires Dark Blue Therapeutics, Bolstering Oncology Pipeline

Alumis’s oral TYK2 inhibitor envudeucitinib cleared both phase 3 psoriasis trials, and the shares more than doubled.

Envudeucitinib met all primary and secondary endpoints in the ONWARD1 and ONWARD2 studies in moderate-to-severe plaque psoriasis, with 74% of patients reaching PASI 75 and 59% reaching clear or almost-clear skin at week 16, deepening to nearly 65% at PASI 90 by week 24. The next-generation, highly selective drug beat Otezla across skin-clearance measures and sets up a filing against BMS’s Sotyktu, the only oral TYK2 drug on the market. Alumis plans to submit to the FDA in H2 2026.

• Alumis’ Envudeucitinib Delivers Leading Skin Clearance Among Next-Generation Oral Plaque Psoriasis Therapies in Phase 3 Program

STAAR Surgical’s shareholders voted down Alcon’s $30.75-a-share takeover, ending months of open conflict.

STAAR said a shareholder meeting had failed to approve its merger with Alcon, and that it would terminate the agreement and stay independent on Nasdaq. Alcon had raised its all-cash offer to $30.75 a share, a 74% premium to STAAR’s 90-day average, but ran into Broadwood Partners, STAAR’s largest holder at 30.2%, which campaigned against the deal. No termination fee is payable by either side.

• STAAR Surgical Announces Preliminary Results of Special Meeting of Stockholders

• Alcon Announces Amended Merger Agreement with STAAR Surgical

Wednesday 7 January

GSK and Ionis said their hepatitis B drug bepirovirsen met its goal in two phase 3 trials, raising the prospect of a functional cure.

Across >1,800 patients in 29 countries, B-Well 1 and 2 showed bepirovirsen plus standard care significantly improved functional cure rates versus standard care, particularly where baseline surface-antigen levels ≤1,000 IU/ml. GSK licensed the antisense oligo from Ionis. A functional cure with sustained viral suppression off treatment, has long eluded a disease normally managed with lifelong antivirals. GSK plans global filings from Q1 2026.

• GSK announces positive results from B-Well 1 and B-Well 2 phase III trials for bepirovirsen, a potential first-in-class treatment for chronic hepatitis B

Eli Lilly agreed to buy Ventyx Biosciences for $1.2bn

Lilly will pay $14.00 a share in cash, a 62% premium to Ventyx’s 30-day average, valuing the biotech at about $1.2bn. Ventyx brings a pipeline of oral drugs against the NLRP3 inflammasome, a pathway tied to cardiometabolic, neurodegenerative and autoimmune disease, and the deal is expected to close in H1 2026. Lilly R&D chief Daniel Skovronsky said “inflammation is a key driver of many chronic diseases“.

• Lilly to acquire Ventyx Biosciences to advance oral therapies targeting inflammatory-mediated diseases

Thursday 8 January

Merck was reported to be in talks to buy Revolution Medicines for up to $32bn, which would be the biggest healthcare deal since Pfizer bought Seagen.

The Financial Times reported on Thursday that Merck & Co was in talks to acquire Revolution Medicines at a valuation of $28bn to $32bn, sending the biotech’s shares higher. The attraction of Revolution’s is daraxonrasib, an oral RAS(ON) inhibitor in late-stage trials for pancreatic and lung cancers, the leading asset in a class big pharma has chased for years. Earlier in the week the Wall Street Journal had reported that AbbVie was close to a deal, but it told Reuters it “is not in discussions with Revolution Medicines“. Neither company confirmed the talks, said to be weeks from agreement.

• AbbVie denies media reports of talks to buy Revolution Medicines - Reuters

• Revolution Medicines Draws Takeover Interest - Wall Street Journal

• Merck in talks to buy Revolution Medicines in up to $32bn deal - Financial Times

An Oxford-led review projected that people who stop obesity drugs regain the weight within about two years, reversing the metabolic gains.

A University of Oxford analysis of 37 studies covering 9,341 people found patients regained about 0.4 kg a month after stopping weight-loss drugs, returning to their starting weight in roughly 1.7 years. Cardiometabolic markers reverted within 1.4 years. Weight returned almost four times faster than after diet-and-exercise programmes. Writing in The BMJ, the authors said drugs alone may not deliver lasting control and urged health systems to plan for millions expected to stop treatment.

• New study finds that stopping weight-loss drugs is linked to faster regain than ending diet programmes - University of Oxford

• Weight regain after cessation of medication for weight management: systematic review and meta-analysis - The BMJ

Friday 9 January

Aktis Oncology priced a $318m IPO, the first biotech listing of 2026.

The radiopharmaceutical developer priced an upsized offering of 17.65m shares at $18 after Thursday’s close in New York, above its range, for gross proceeds of $318m, with the offering expected to close on 12 January. Its shares were set to begin trading on Nasdaq as “AKTS” on 9 January. Existing partner Eli Lilly had indicated an interest in buying about $100m of the stock, roughly a third of the deal. Aktis builds miniprotein radioconjugates that carry radiation to tumours; its lead candidate targets Nectin-4.

• Aktis Oncology Announces Pricing of its Upsized Initial Public Offering

• Aktis Oncology, Form S-1/A - SEC EDGAR

ALETH · OPEN ACCESS RESEARCH

aleth.co

The Aleth Briefs trace each story to its original source and show how the week unfolded.

The week in four lines

• Insilico completed Hong Kong’s largest biotech IPO of 2025

• Mereo and Ultragenyx‘s bone drug missed its fracture endpoints.

• Vanda won approval of the first new motion-sickness drug in 40 years.

• A judge blocked the US 340B rebate pilot.

In this edition

• Tuesday: Genmab lung cancer; Mereo-Ultragenyx bone drug; US 340B block; Insilico Hong Kong IPO; Vanda motion sickness

• Wednesday: Corcept cortisol rejection

Tuesday 30 December

Genmab dropped acasunlimab, its phase 3 lung-cancer bispecific antibody.

Genmab will stop developing acasunlimab after a portfolio review, redirecting resources to Epkinly, petosemtamab and rinatabart sesutecan (Rina-S). The bispecific had reached phase 3 in non-small cell lung cancer, alone and with Merck & Co’s Keytruda, in patients progressing after checkpoint inhibition. BioNTech returned its rights in 2024. Genmab said the data were encouraging but it would prioritise higher-impact late-stage programmes in a crowded field.

• Genmab Portfolio Prioritization Update

Setrusumab missed the fracture endpoint in both phase 3 trials, hitting Ultragenyx and UK partner Mereo.

Setrusumab missed its primary endpoint in both pivotal osteogenesis imperfecta trials. ORBIT compared 159 patients aged 5–25 with placebo, while COSMIC compared 69 children aged 2–6 with intravenous bisphosphonates. Neither study significantly reduced annual clinical fractures, although both improved bone mineral density and showed a consistent safety profile. The companies blamed an unexpectedly low fracture rate in ORBIT’s placebo group. Both shares fell sharply.

• Ultragenyx Announces Phase 3 Orbit and Cosmic Results for Setrusumab (UX143)

• Phase 3 ORBIT and COSMIC results - Mereo BioPharma

A federal judge blocked the US 340B rebate pilot a day before it was to start.

A Maine district judge granted a nationwide preliminary injunction blocking HRSA’s 340B Rebate Model Pilot Program from launching on 1 January 2026. The court found HRSA likely acted arbitrarily by failing to consider hospitals’ longstanding reliance on upfront 340B discounts before shifting to full-price purchases followed by rebates. The order blocks nine manufacturers’ applications covering ten drugs and applies to all 340B providers, not only the hospital groups that brought the case.

• American Hospital Association v Kennedy: order on motion for preliminary injunction - US District Court for the District of Maine

Insilico Medicine raised HK$2.3bn in Hong Kong, the year’s largest biotech listing there.

AI drug-discovery company Insilico Medicine listed on the Hong Kong Stock Exchange, raising about HK$2.28 billion ($293m) at HK$24.05 a share, the largest Hong Kong biotech IPO of 2025. The Hong Kong retail tranche was oversubscribed 1,427 times and the international offering 26 times, with 15 cornerstone investors including Eli Lilly and Tencent. Insilico uses generative AI to design drug candidates and runs programmes in fibrosis, immuno-oncology and cardiometabolic disease.

• Insilico Medicine Lists on Hong Kong Stock Exchange, Showing AI Drug Discovery Momentum with 2025’s Largest Hong Kong Biotech IPO

Vanda’s Nereus, the 1st new motion-sickness drug in >40 years, was approved

The FDA approved Vanda Pharmaceuticals’ Nereus (tradipitant), an oral neurokinin-1 (NK-1) receptor antagonist, to prevent motion-induced vomiting in adults. It is the first new pharmacological treatment for motion sickness in >40 years. In the Motion Syros trial (365 participants) and Motion Serifos (316 participants), vomiting rates on Nereus ran at roughly 10% to 20% against 38% to 44% on placebo. The clearance was the FDA’s final new drug approval of 2025.

• Vanda Pharmaceuticals Announces FDA Approval of NEREUS (tradipitant) for the Prevention of Vomiting Induced by Motion

• NDA 220152 approval letter: Nereus (tradipitant) - FDA

Wednesday 31 December

The FDA rejected Corcept’s relacorilant for hypertension secondary to hypercortisolism.

The FDA issued a complete response letter for Corcept Therapeutics’ relacorilant in hypertension caused by Cushing’s syndrome. Although the phase 3 GRACE trial met its primary endpoint, the agency said GRADIENT’s failure on systolic blood pressure left insufficient evidence of effectiveness to establish a favourable benefit-risk profile. Corcept, which positioned relacorilant as a cleaner successor to Korlym, plans to discuss a path forward with the FDA.

• Corcept Receives Complete Response Letter for Relacorilant as a Treatment for Patients with Hypercortisolism

ALETH · OPEN ACCESS RESEARCH

aleth.co

The Aleth Briefs trace each story to its original source and show how the week unfolded.

The week in five lines

• The FDA cleared Novo Nordisk‘s Wegovy obesity pill.

• BioMarin bought Amicus Therapeutics for $4.8bn.

• The White House struck nine more drug-pricing deals.

• CMS proposed mandatory international pricing for Medicare.

• A jury hit Johnson & Johnson with $1.56bn over talc.

In this edition

• Weekend catch-up: BioMarin-Amicus; US pricing; Medicare models; Cytokinetics approval; BI fibrosis nod; AZ-Jacobio; Samsung-GSK; Roche Lunsumio

• Monday: Novo obesity pill; Shionogi-Radicava; US talc verdict; AZ lung miss; Neurocrine failure; Pfizer trial death; Abbott Volt; Guardant Japan

• Tuesday: Edwards mitral valve

• Weekend catch-up: Diasorin POC clearance

Weekend catch-up (20 December-21 December)

BioMarin agreed to buy Amicus Therapeutics for $4.8bn in cash.

BioMarin will pay $14.50 a share, a 33% premium to last close and 58% to 60-day average, using cash and $3.7bn of new debt. Amicus brings Galafold in Fabry disease and Pombiliti with Opfolda in Pompe disease, which generated $599m over the past 12 months, plus US rights to phase 3 kidney candidate DMX-200. Expected to close in Q2 2026. BioMarin also disclosed that it had discontinued BMN 349, its oral candidate for alpha-1 antitrypsin deficiency (AATD) liver disease.

• BioMarin to acquire Amicus Therapeutics for $4.8 billion

• BioMarin, Amicus strike a $4.8 billion rare disease deal - BioPharma Dive

The White House announced MFN pricing deals with nine more drugmakers.

Nine major drugmakers agreed to extend most-favoured-nation prices to every state Medicaid programme and sell direct through TrumpRx below list price. The fact sheet cites Repatha falling from $573 to $239 and Epclusa from $24,920 to $2,425. The companies guaranteed MFN pricing for new launches and committed >$150bn in US manufacturing and research investments. The agreements bring the administration’s total to 14 since 30 September. Trump said insurers were next.

• Fact sheet: President Donald J Trump announces the largest developments to date in bringing most favored nation pricing to American patients - The White House

• Administration reaches deals with nine drug companies to lower drug costs - AHA

CMS proposed two mandatory Medicare models that tie rebates to what other rich countries pay.

GLOBE would cover Part B from 1 October 2026 and GUARD Part D from 1 January 2027, each reaching areas representing about a quarter of relevant patients. Both would replace the domestic inflation-rebate benchmark with one based on 19 OECD countries, including the UK, adjusted for purchasing power, and would be compulsory for drugs in scope. CMS estimates savings of $11.9bn and $14.1bn. PhRMA warned the proposals would divert billions from US drug R&D as China closes the gap.

• Global Benchmark for Efficient Drug Pricing (GLOBE) Model - Federal Register

• Guarding US Medicare Against Rising Drug Costs (GUARD) Model - Federal Register

Cytokinetics won FDA approval for its first product Myqorzo.

Myqorzo (aficamten), a once-daily cardiac myosin inhibitor, was cleared for adults with symptomatic obstructive hypertrophic cardiomyopathy ahead of its 26 December deadline. In phase 3 SEQUOIA-HCM, peak oxygen uptake rose 1.8 mL/kg/min at 24 weeks versus no change on placebo. A boxed warning and REMS requiring echocardiograms make monitoring a key issue against Camzyos. US launch is planned for the second half of January. Both China and the EU CHMP recently backed the drug.

• Cytokinetics announces FDA approval of Myqorzo (aficamten) for adults with symptomatic obstructive hypertrophic cardiomyopathy

• Cytokinetics wins first approval, setting up a fight with BMS - BioPharma Dive

The FDA approved Boehringer’s Jascayd for progressive pulmonary fibrosis.

Jascayd (nerandomilast), a preferential PDE4B inhibitor, is the second drug approved for the indication and the first since Ofev in 2020. In phase 3 FIBRONEER-ILD, forced vital capacity fell 86 mL on 18 mg and 69 mL on 9 mg at 52 weeks, versus 152 mL on placebo. The trial allowed continued Ofev use; diarrhoea affected about half of those patients versus 37% on placebo plus Ofev. Adverse events were similar across groups.

• FDA approves nerandomilast for progressive pulmonary fibrosis - PF Foundation

• FDA approves Jascayd for treatment of progressiv pulmonary fibrosis - BI

AstraZeneca licensed a pan-KRAS inhibitor from China’s Jacobio for up to $2bn.

AZ paid $100m upfront for JAB-23E73, with up to $1.92bn in milestones and tiered royalties, taking global rights ex-China, where the two will develop and sell it together. The drug is in phase 1 in China and the US. KRAS mutations are present in about 23% of cancer patients, and the two approved inhibitors, Amgen’s Lumakras (sotorasib) and BMS’s Krazati (adagrasib), reach only the G12C variant, leaving the G12D and G12V mutations that dominate pancreatic and colorectal disease untreated.

• Jacobio enters a global license agreement with AstraZeneca for JAB-23E73

Samsung Biologics agreed to buy Human Genome Sciences from GSK for $280m.

Coming soon after Congress passed The Biosecure Act, the deal hands the Korean CMO its first US plants: two cGMP facilities at Rockville, Maryland with a combined 60,000 litres of drug substance capacity and >500 staff (vs 785k litres at home). Samsung will keep making GSK’s existing products there, with closing expected by the end of Q1 2026. GSK bought Human Genome Sciences in 2012 for about $3bn.

• Samsung Biologics expands US manufacturing capabilities with a strategic acquisition from GSK

• Samsung Biologics to buy GSK’s US plant for $280 million - The Korea Herald

The FDA approved Genentech’s Lunsumio for relapsed follicular lymphoma.

Lunsumio VELO, administered in a minute rather than a 2-4 hr infusion, received accelerated approval for adults with relapsed or refractory follicular lymphoma after two or more lines. In phase 1/2 GO29781, the response rate was 75%, including 59% complete responses, with median response duration of 22.4 months. Cytokine release syndrome affected 30%, grade 3 in 2.1%. Genentech is positioning its fixed eight-cycle course against subcutaneous Epkinly, which moved into second line a month earlier.

• FDA approves Genentech’s Lunsumio VELO for relapsed follicular lymphoma

• AbbVie announces FDA approval of Epkinly for relapsed follicular lymphoma

Monday 22 December

The FDA approved a pill version of Wegovy, the first oral GLP-1 for weight loss.

The once-daily 25 mg semaglutide tablet is cleared both to reduce and maintain weight loss and to cut major cardiovascular events in overweight or obese adults with established cardiovascular disease. In the 64-week phase 3b OASIS 4 trial, 307 patients lost 16.6% of body weight, which Novo Nordisk says is similar to injectable Wegovy 2.4 mg, and one in three lost >20%. Novo will priced the 1.5 mg starting dose at $149 a month and said it would launch in the US in early January.

• Novo Nordisk announces FDA approval of the Wegovy pill

Shionogi agreed to pay $2.5bn for Tanabe Pharma’s ALS franchise.

Shionogi is buying a new company holding global rights to Radicava (edaravone), in both its intravenous and oral suspension forms, for a lump sum plus a possible royalty on future sales. It expects the franchise to add about $700m in annual global sales and to be accretive in its 2026 financial year, with closing on or after 1 April 2026. Shionogi said the purchase gives it a US rare-disease commercial platform ahead of its own planned launches in Fragile X, Jordan’s syndrome and Pompe disease.

• Shionogi expands rare disease presence with acquisition of global rights to Radicava

A Baltimore jury ordered Johnson & Johnson to pay $1.56bn over talc-based baby powder.

Cherie Craft, 54, developed peritoneal mesothelioma after using talc powder for >40 years. A Baltimore jury awarded $59.8m in compensatory damages and $1.5bn in punitive damages against J&J and Pecos River Talc, finding J&J, two units and Kenvue liable for failure to warn. It is the largest talc award to a single plaintiff, amid >70,000 pending claims. J&J called the verdict unconstitutional and said it would appeal.

• Johnson & Johnson statement on the Craft verdict

• J&J talc jury awards $1.56 billion to asbestos cancer victim - Claims Journal

AZ’s ceralasertib missed overall survival in the phase 3 LATIFY lung-cancer trial.

The 594-patient study tested the oral ATR inhibitor with Imfinzi against docetaxel in locally advanced or metastatic non-small cell lung cancer without actionable genomic alterations, in patients who had progressed on immunotherapy and platinum chemotherapy. Safety was consistent with the known profiles of both medicines, with no new concerns. The data will be presented at a forthcoming medical meeting.

• Update on the LATIFY phase III trial of ceralasertib - AstraZeneca

Neurocrine’s Ingrezza failed its phase 3 trial in dyskinetic cerebral palsy.

KINECT-DCP randomised 86 people aged 6 to 70 with choreiform movements to Ingrezza (valbenazine) or placebo for 14 weeks and missed both its primary endpoint, chorea score on the Unified Huntington Disease Rating Scale, and its key secondary endpoints. Nothing is approved for dyskinetic cerebral palsy, which accounts for about 15% of cerebral palsy cases; Ingrezza is already cleared in tardive dyskinesia and Huntington’s chorea, and sold $687m in Q3 2025, up 12% YoY.

• Neurocrine Biosciences provides an update on the phase 3 study of valbenazine in dyskinetic cerebral palsy

• Neurocrine Biosciences reports third quarter 2025 financial results

Pfizer told haemophilia groups that a patient in a Hympavzi study had died.

A haemophilia A patient with inhibitors treated with weekly Hympavzi for three years, suffered a cerebellar infarction followed by cerebral haemorrhage after a minor urethroscopic procedure managed with recombinant factor VIIa. Pfizer is assessing causality with an independent monitoring committee, and advised close thrombosis monitoring around surgery when clotting factors or bypassing agents are used. Hympavzi was approved in the US in October 2024 only for patients without inhibitors.

• WFH and NBDF statement on a severe adverse event with marstacimab - World Federation of Hemophilia

• Statement on the marstacimab clinical trial adverse event - Coalition for Hemophilia B

Abbott won FDA approval for its Volt pulsed field ablation system.

The clearance covers symptomatic, recurrent, drug-refractory paroxysmal or persistent atrial fibrillation lasting under a year, and makes Abbott another major cardiac-device maker to enter the US pulsed-field ablation market. In the 392-patient VOLT-AF study, serious device- or procedure-related events within seven days were 1.9%; six-month freedom from recurrence was 93.1% in paroxysmal and 81.9% in persistent AF.

• Abbott’s Volt pulsed field ablation system receives FDA approval to treat patients with atrial fibrillation

• Premarket Approval (PMA) - FDA

Japan approved Guardant test as companion diagnostic for Lilly’s imlunestrant.

Guardant Health said the health ministry cleared Guardant360 CDx to detect ESR1 mutations in hormone receptor-positive, HER2-negative metastatic or recurrent breast cancer after endocrine therapy. Announced alongside approval of Lilly’s oral degrader, it is Japan’s first blood-based companion diagnostic for ESR1, found in 20% to 40% of patients previously treated with an aromatase inhibitor. In phase 3 EMBER-3, median progression-free survival was 5.49 months versus 3.84 on standard endocrine therapy.

• Guardant Health Japan receives regulatory approval of Guardant360 CDx as a companion diagnostic for imlunestrant

• Japanese approval of imlunestrant (EL25-74) - Eli Lilly Japan

Tuesday 23 December

The FDA approved Edwards Lifesciences’ Sapien M3, the first transseptal mitral valve replacement.

The valve is delivered through the femoral vein and septum in two steps, dock then valve, for patients unsuitable for surgery or edge-to-edge repair, including those with annular calcification. In the 299-patient ENCIRCLE trial, 95.7% had trace or mild regurgitation at one year, while 25.2% died or were hospitalised for heart failure, within the performance goal. Abbott’s Tendyne instead enters through the chest wall.

• FDA approves Edwards Lifesciences’ Sapien M3 mitral valve replacement system

• FDA approves Sapien M3 for transseptal mitral valve replacement - TCTMD

Weekend catch-up (27 December-28 December)

Diasorin won FDA clearance and a CLIA waiver for a four-in-one respiratory test.

The LIAISON NES panel separates influenza A, influenza B, RSV and SARS-CoV-2 from a dry nasal swab in 15 minutes across a three-step workflow, and the waiver lets it run in doctors’ surgeries and urgent care rather than certified laboratories. It is Diasorin’s first molecular point-of-care product, developed with an unnamed large US pharmacy chain and funded in part by BARDA.

• FDA clearance for the LIAISON NES FLU A/B, RSV & COVID-19 panel - Diasorin

• 510(k) premarket notification K251978 - FDA

ALETH · OPEN ACCESS RESEARCH

aleth.co

The Aleth Briefs trace each story to its original source and show how the week unfolded.

The week in five lines

• Brussels unveiled its EU Biotech Act.

• Sanofi struck two biotech deals in one day.

• The US CDC ended universal newborn hepatitis B dosing.

• Medline raised $6.3bn in the year’s biggest IPO.

• The US Biosecure Act was signed into law.

In this edition

• Weekend catch-up: Arcus/Gilead TIGIT failure; Innoviva gonorrhoea; Sobi-Arthrosi

• Monday: Sanofi MS & $2.8bn deal day; Enhertu first-line; FDA on Covid vaccines

• Tuesday: EU Biotech; Medline record IPO; GSK asthma approval; US hep B; Pfizer

• Wednesday: US Biosecure Act becomes law

• Thursday: Takeda psoriasis pill; Novo CagriSema filing; Daiichi-Merck ADC hold

Weekend catch-up

Arcus Biosciences and Gilead abandon upper-GI domvanalimab studies on phase 3 futility.

On Friday the partners said the phase 3 STAR-221 study in first-line advanced gastric and oesophageal cancer had been stopped for futility on the recommendation of its monitoring committee. The anti-TIGIT antibody domvanalimab with zimberelimab and chemotherapy did not improve overall survival against Opdivo (nivolumab) and chemotherapy across 1,040 patients. STAR-221 is another heavy setback for a class that Roche, Merck and BMS have stepped back from.

• Arcus provides update on the phase 3 STAR-221 study

• Gilead provides update on the phase 3 STAR-221 study

Innoviva won FDA approval for Nuzolvence, the second first-in-class oral gonorrhoea antibiotic cleared in as many days.

On Friday, a day after GSK’s Blujepa, the FDA approved Innoviva’s Nuzolvence (zoliflodacin), a single-dose oral antibiotic for uncomplicated urogenital gonorrhoea in patients aged 12 and over weighing at least 35 kg. Approval rested on a phase 3 trial in 930 patients in which one dose was non-inferior to injectable ceftriaxone plus oral azithromycin. Developed with the non-profit Global Antibiotic Research and Development Partnership.

• US FDA approves Nuzolvence (zoliflodacin) - Innoviva

• FDA approves two new oral gonorrhea antibiotics

Sweden’s Sobi agreed to buy Arthrosi Therapeutics for up to $1.5bn.

Announced on Saturday, the deal pays $950m upfront in cash with up to $550m more in clinical, regulatory and sales milestones. It brings pozdeutinurad (AR882), a once-daily oral URAT1 inhibitor in two fully enrolled phase 3 trials in progressive and tophaceous gout, with data due in 2026. The sale came shortly after Arthrosi closed a $153m series E. The acquisition takes rare-disease specialist Sobi into a common disease area where there have been few late-stage deals of this scale.

• Sobi to acquire Arthrosi Therapeutics

• Arthrosi secures $153 million in Series E financing

Monday 15 December

Sanofi’s BTK inhibitor tolebrutinib failed a phase 3 in primary progressive MS.

The phase 3 PERSEUS study in primary progressive multiple sclerosis, which accounts for about a tenth of MS, missed its primary endpoint. with no significant delay to confirmed disability progression against placebo. Sanofi will not seek registration in that disease form but remains confident in the drug for non-relapsing secondary progressive MS, where a US decision is pending.

• Sanofi reports topline PERSEUS phase 3 results for tolebrutinib

Sanofi announced two biotech deals in one day worth up to $2.8bn.

Sanofi expanded its collaboration with Dren Bio, paying $100m upfront and up to $1.7bn in milestones for a next-generation B-cell-depleting therapy for autoimmune disease, building on its acquisition of Dren’s DR-0201 earlier in the year. Hours later it licensed ADEL-Y01, a tau-targeting Alzheimer’s antibody from South Korea’s ADEL, for $80m upfront within a total potential value of up to $1.04bn, plus tiered royalties.

• Dren Bio expands its strategic collaboration with Sanofi

• ADEL signs a $1.04 billion global licence agreement with Sanofi for ADEL-Y01

The FDA approved Enhertu with Perjeta for first-line HER2-positive metastatic breast cancer.

The clearance, announced by AstraZeneca and Daiichi Sankyo, moves the antibody-drug conjugate Enhertu (trastuzumab deruxtecan) into the front line alongside Roche’s Perjeta (pertuzumab), the first new first-line option in over a decade. In the phase 3 DESTINY-Breast09 trial the combination cut the risk of disease progression or death by 44% against the standard taxane, trastuzumab and pertuzumab regimen, with median progression-free survival of 40.7 months against 26.9 months.

• Enhertu+pertuzumab approved in US for 1st-line HER2+ve metastatic breast cancer

The FDA said it has no plans to put a boxed warning on Covid-19 vaccines.

FDA commissioner Marty Makary said the agency had no plans to add a boxed warning, its strongest label, to Covid-19 vaccines, contradicting a report days earlier that it was preparing to. He said some officials had recommended the warning but that leadership, including CBER director Vinay Prasad, did not consider it necessary. The exchange is the latest turn in an internal fight over vaccine safety messaging under the current US health leadership.

• FDA denies plan for a black box warning on Covid-19 vaccines - The Hill

Tuesday 16 December

The European Commission unveiled an EU Biotech Act to slow biotech’s drift to the US and China.

In an initiative meant to close Europe’s innovation gap: the commission proposed faster clinical trials, smoother rules for cell and gene therapies, more biomanufacturing capacity and easier access to capital for start-ups, alongside new biosecurity screening. The Commission notes that EU biotech has grown at roughly twice the rate of the wider economy over a decade, contributing about €40bn to GDP.

• Q&A on the European Biotech Act - European Commission

Medline raised $6.27bn in the biggest IPO of 2025.

The medical-supplies group, taken private in 2021 by Blackstone, Carlyle and Hellman & Friedman, priced 216 million shares at $29, the largest private-equity-backed listing on record by money raised. Shares began trading on the Nasdaq and jumped about 41% to around $41. Medline had shelved an earlier 2025 listing attempt because its China-heavy supply chain left it exposed to tariffs.

• Medline announces the pricing of its upsized IPO - Medline

• Medline debuts on the Nasdaq in the biggest IPO of 2025 - CNBC

The FDA approved GSK’s twice-yearly asthma biologic Exdensur.

Exdensur (depemokimab) is an ultra-long-acting anti-IL-5 antibody dosed every six months, cleared as add-on maintenance for severe asthma with an eosinophilic phenotype in patients age 12 and over. In the phase 3 SWIFT-1 and SWIFT-2 trials it cut annual exacerbations by 58% and 48% against placebo over 52 weeks. GSK has guided to around £3bn ($4bn) in peak-year sales for the drug.

• Exdensur (depemokimab) approved by the US FDA for severe asthma - GSK

• GSK closes on approval of asthma hope depemokimab - pharmaphorum

The US CDC ended recommendation newborns receive a hepatitis B vaccine.

The CDC adopted the change following an 8-3 vote by its reshaped advisory committee on 5 December to replace the universal birth-dose policy, in place since 1991, moving to shared decision-making for babies born to mothers testing negative for hepatitis B. Where a mother is positive or status unknown, the birth dose and immunoglobulin still stand. Paediatric groups have opposed the move, the latest change to the US childhood schedule under health secretary Robert F Kennedy Jr.

• CDC hepatitis B immunization fact sheet

• CDC recommends individual-based decision-making for the hepatitis B vaccine in infants born to hepatitis B-negative mothers

• CDC’s ACIP changes recommendations for hepatitis B vaccination for infants - NPR

Pfizer guided to lower 2026 revenue and leaned on obesity to fill the gap.

Pfizer forecast 2026 revenue of $59.5bn to $62.5bn, a midpoint below this year, and its shares fell about 5%. Falling Covid sales and a multi-billion-dollar patent cliff sit behind the outlook. The company plans around 20 pivotal trials next year, ten of them on the ultra-long-acting obesity assets it gained in its $10bn Metsera acquisition, its bet to rebuild growth after dropping two earlier obesity candidates.

• Pfizer 2026 financial guidance - SEC (Pfizer Form 8-K)

• Pfizer leans on obesity in its 2026 guidance - CNBC

Wednesday 17 December

The US Senate cleared the Biosecure Act, sending it to become law.

The Senate passed the 2026 National Defense Authorization Act by 77 to 20, carrying with it a softened Biosecure Act as Section 851. The provisions restrict federal contracts with biotech companies that the Office of Management and Budget designates as “companies of concern”; the enacted text names no firms and takes effect only after later guidance. The House had passed the package on 10 December. It ends a two-year effort that had repeatedly failed as standalone legislation.

• BIOSECURE Act included in the FY2026 National Defense Authorization Act - Sidley

• SASC leaders commend final passage of the FY2026 National Defense Authorization Act - US Senate Committee on Armed Services

• Statement by the President on S. 1071 - The White House

Thursday 18 December

Takeda’s zasocitinib cleared two phase 3 psoriasis trials.

Takeda said the once-daily oral TYK2 inhibitor met co-primary endpoints in two LATITUDE-PsO studies in moderate-to-severe plaque psoriasis: >50% patients reached PASI 90, near-clear skin, at 16 weeks. Takeda, which acquired the molecule from Nimbus in 2023, plans to file in the US in FY2026. An oral that matches the class on skin clearance would set it against BMS’s Sotyktu in a crowded market.

• Takeda’s zasocitinib delivers positive phase 3 plaque psoriasis data

• Takeda completes acquisition of Nimbus Therapeutics’ TYK2 programme subsidiary

Novo Nordisk filed its next big obesity bet CagriSema for US approval.

Novo submitted a marketing application to the FDA for CagriSema, a once-weekly injection combining amylin analogue cagrilintide with semaglutide. In the phase 3 REDEFINE 1 it produced weight loss of 20.4% against 3.0% on placebo, rising towards 23% in patients who stayed on treatment. The filing is Novo’s attempt to strengthen its semaglutide franchise and counter Eli Lilly at the top of the obesity market.

Novo Nordisk files for FDA approval of CagriSema - Novo Nordisk

An October FDA hold on Daiichi-Merck’s I-DXd lung-cancer trial comes to light.

Trade reporting disclosed the FDA had verbally placed the phase 3 IDeate-Lung02 trial in small-cell lung cancer on partial clinical hold in October, after a higher-than-expected number of fatal interstitial lung disease events. The trial is of ifinatamab deruxtecan (I-DXd), an ADC in Daiichi Sankyo and Merck’s oncology alliance.

• Patient deaths prompt partial hold on Daiichi/Merck’s phase 3 ADC - Fierce Biotech

• Merck/Daiichi ifinatamab deruxtecan hit with clinical hold - BioPharma Dive

ALETH · OPEN ACCESS RESEARCH

aleth.co

The Aleth Briefs trace each story to its original source and show how the week unfolded.

The week in five lines

• The UK cut its drug rebate to win back pharma.

• Lilly‘s retatrutide posted significant 28.7% weight loss.

• Novartis and Relation strike AI deal worth up to $1.7bn.

• The Biosecure Act cleared the US House.

• The EU agreed its biggest pharma overhaul in decades.

In this edition

• Weekend catch-up: Natera-Foresight MRD; BioNTech lung cancer

• Monday: UK biotech fund; Mirum-Bluejay; Dyne Duchenne; FDA CAR-T bar

• Tuesday: Novartis-Relation; Biosecure Act; Pfizer-China GLP-1; Medline IPO

• Wednesday: UK drug rebate; record biotech follow-on

• Thursday: EU pharma; Lilly retatrutide; GSK gonorrhoea & Walmsley; Amgen

Weekend catch-up

Natera bought Foresight Diagnostics for up to $450m, entering blood cancer.

Announced on Friday, the all-stock deal pays $275m upfront with up to $175m more tied to revenue and reimbursement milestones. Foresight’s ultrasensitive PhasED-Seq platform detects molecular residual disease (MRD) in lymphoma from a blood sample, complementing Natera’s Signatera MRD testing in solid tumours. Natera plans to fold the phased-variant technology into Signatera, with a clinical launch expected in 2026.

• Natera acquires Foresight Diagnostics

BioNTech / OncoC4’s gotistobart more than halved mortality risk in a phase 3 lung-cancer trial.

Reported on Saturday, the non-pivotal dose-confirmation stage of the phase 3 PRESERVE-003 trial showed gotistobart cutting the risk of death by more than half versus chemotherapy in squamous non-small cell lung cancer (NSCLC) that had progressed after immunotherapy and chemotherapy. Median overall survival was not reached at 15 months, versus 10 months for chemotherapy, although tolerability was demanding. BioNTech is pushing beyond Covid vaccines into oncology.

• BioNTech and OncoC4 announce clinically meaningful overall survival benefit for gotistobart in previously treated squamous NSCLC

Monday 8 December

The British Business Bank agreed a $100m commitment to SV Health’s SV8 biotech fund.

The cornerstone commitment to the $500m SV8 Biotech Fund is the state bank’s biggest since it was formed in 2014, and takes its life-sciences fund commitments past £560m across 15 funds. The government widened the bank’s capacity this year to speed backing for UK growth companies.

• British Business Bank to commit $100m to SV Health Investors’ SV8 Biotech, the bank’s largest fund commitment

Mirum Pharmaceuticals agreed to buy Bluejay Therapeutics for $620m, adding a phase 3 hepatitis D antibody.

Mirum will pay $250m in cash and $370m in stock, with up to $200m more in sales milestones, for brelovitug, a monoclonal antibody in the global phase 3 AZURE programme for chronic hepatitis delta, a liver infection with little approved treatment in the US. Topline data are expected in H2 2026. The purchase extends Mirum’s existing rare liver disease business rather than opening a new one.

• Mirum Pharmaceuticals enters into agreement to acquire Bluejay Therapeutics

Dyne Therapeutics’ Duchenne drug hit its goal in a registrational study and is heading to the FDA.

In the registrational expansion cohort of the phase 1/2 DELIVER trial, z-rostudirsen (DYNE-251) raised muscle-adjusted dystrophin to 5.46% of normal at six months (p<0.0001) in Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping, with functional gains. Dyne plans to seek US accelerated approval in Q2 2026 and targets a possible Q1 2027 launch if granted priority review. DMD approvals have historically relied on surrogate data, so a clean registrational read strengthens its case.

• Dyne Therapeutics announces positive topline results from phase 1/2 DELIVER trial

The FDA said new cancer CAR-T therapies should beat those already approved.

In a JAMA paper, CBER director Vinay Prasad and colleagues set randomised trials showing superiority over standard care, including approved CAR-Ts, as the agency’s preferred route to approval, a move beyond the single-arm studies behind all seven marketed CAR-T therapies. Single-group trials would still be considered where a randomised one is not feasible, as in rare or heavily pre-treated groups. Head-to-head studies cost more and take longer, and several programmes were not built for them.

• Advancing CAR T-cell therapy: evidence-based trial design for chimeric antigen receptor T-cell therapy in oncology - JAMA

Tuesday 9 December

Novartis struck an atopic-disease discovery deal with UK biotech Relation Therapeutics worth up to $1.7bn.

Relation will receive $55m upfront through equity investment and research funding, with up to $1.7bn in additional milestones, along with tiered royalties. The collaboration pairs Relation’s AI-led, patient-data discovery platform with Novartis’s immuno-dermatology expertise to identify first-in-class targets for allergic diseases. It represents another major pharma investment in AI-led target discovery.

• Relation announces a strategic collaboration with Novartis to advance therapeutics for atopic diseases

A softened Biosecure Act was folded into US defence bill and cleared the House.

Text released on Tuesday wrote the measure into the 2026 National Defense Authorization Act, and the House passed the bill on Wednesday, with the Senate still to act. It would bar named Chinese contract research and manufacturing firms, and companies that work with them, from federal contracts from 2026. Unlike last year’s version it targets firms tied to China’s military rather than naming WuXi AppTec or WuXi Biologics. Many US biopharma companies rely on Chinese suppliers.

• Biosecure Act slips into key US defense bill - Fierce

• S. 1071 (119th Congress): Biosecure Act - all actions - US Congress

• House Committee Print 62380: 2026 National Defense Authorization Act text - US House of Representatives

Pfizer paid $150m upfront for a Chinese GLP-1, expanding its obesity pipeline.

The exclusive global licence for YP05002, an oral small-molecule GLP-1 in phase 1 from YaoPharma, a Shanghai Fosun Pharmaceutical unit, carries up to $1.935bn in milestones and tiered royalties. Pfizer discontinued danuglipron in April 2025 and completed its acquisition of Metsera in November. This is another instance of big pharma sourcing obesity assets from China rather than building them in-house.

• Pfizer enters into an exclusive collaboration and licence agreement with YaoPharma

The FDA approved the first gene therapy taken through approval by a nonprofit.

Waskyra (etuvetidigene autotemcel), from Italy’s Fondazione Telethon, treats Wiskott-Aldrich syndrome, an inherited immune and bleeding disorder, by adding working copies of the WAS gene to a patient’s own blood stem cells. As stated by the foundation, it is the first gene therapy a nonprofit has taken through FDA approval, a route that sidesteps the commercial return a company must show, at a time when developers have pulled approved rare-disease gene therapies from the market.

• Fondazione Telethon announces FDA approval of Waskyra (etuvetidigene autotemcel) for Wiskott-Aldrich syndrome - Fondazione Telethon

• Waskyra (etuvetidigene autotemcel) - FDA

Medline set terms for one of largest US healthcares IPOs of up to $5.4bn.

The medical-supplies group, taken private in 2021 by Blackstone, Carlyle and Hellman & Friedman, is offering 179 million shares at $26 to $30. At the top of the range, it would rank among the largest US healthcare IPOs on record.

• Medline sets terms for a massive $5.37bn Nasdaq IPO - Fierce Biotech

• Medline preliminary prospectus (Form S-1/A) - SEC

Wednesday 10 December

The UK cut the headline new-medicines payment rate to 14.5% and lifted its NHS drug bill.

The government set the newer-medicines payment rate under the Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG) at 14.5% for 2026, down from this year’s record 22.9%, honouring the cap agreed in the UK-US trade deal last week. Including a separate 1% investment contribution, the total payment is 15.5%. The government expects the package to produce up to £1bn of additional medicines spending over three years. The ABPI called it a first step back towards competitiveness.

• The 2024 Voluntary Scheme for Branded Medicines Pricing, Access and Growth: payment percentage for 2026 - GOV.UK

• VPAG payment rate for newer medicines will be 14.5% in 2026 - ABPI

Biotechs sold a record $3.2bn of follow-on stock in a single day.

Eight companies raised the money between Tuesday evening and Wednesday morning, with Structure Therapeutics, Terns Pharmaceuticals and Kymera Therapeutics each taking more than $600m off recent data. With the IPO window still shut, this is a leading indicator that public investor appetite for the sector is returning.

• Investors buy up stocks in the biggest follow-on day in biotech history - Endpoints

Thursday 11 December

The EU struck a deal on its biggest overhaul of pharma law in two decades.

Council and Parliament negotiators agreed to set regulatory data protection at eight years plus one year of market protection, and to shorten the EMA review from 210 to 180 days, alongside new shortage-notification duties. Industry body EFPIA called the package encouraging but “not strong enough to move the needle“ on European competitiveness. The provisional deal still needs formal sign-off.

• ‘Pharma package’: Council and Parliament reach a deal on new rules for a fairer and more competitive EU pharmaceutical sector - Council of the European Union

• Background note: pharmaceutical package - European Parliament

• EFPIA response to pharmaceutical package agreement - EFPIA

Lilly’s triple agonist retatrutide posted significant 28.7% weight loss.

In phase 3 TRIUMPH-4, 12 mg retatrutide reduced weight by 28.7% and WOMAC pain by 74.3% in adults with obesity and knee osteoarthritis; treatment-regimen estimates were 23.7% and 62.6%. The GIP, GLP-1 and glucagon receptor agonist is Lilly’s follow-on to Mounjaro. Adverse-event discontinuations were 18.2% versus 4.0% on placebo, while mostly mild dysesthesia affected 20.9%. Reuters cited analysts describing the weight loss as the highest yet, but the overall result as mixed because of side effects.

• Lilly’s triple agonist retatrutide delivered weight loss of up to an average of 71.2 lbs with substantial relief from osteoarthritis pain in first successful phase 3 trial

• Lilly’s next-gen drug tops Zepbound weight loss in late-stage osteoarthritis - Reuters

GSK’s Blujepa won FDA approval for gonorrhoea, the first new-class oral antibiotic for it in three decades.

The FDA cleared Blujepa (gepotidacin), a first-in-class oral antibiotic, for uncomplicated urogenital gonorrhoea in patients aged 12 and over weighing at least 45 kg who have limited or no alternative treatment options. Approval was based on the phase 3 EAGLE-1 trial, in which Blujepa was non-inferior to injectable ceftriaxone plus oral azithromycin. Rising resistance has reduced treatment options for gonorrhoea. GSK is one of the few large pharma companies still developing antibiotics.

• Blujepa (gepotidacin) approved by US FDA as an oral option for uncomplicated urogenital gonorrhoea - GSK

The FDA approved Amgen’s Uplizna in generalised myasthenia gravis.

Uplizna (inebilizumab), a CD19-targeted B-cell depleter, is cleared for adults with the autoimmune neuromuscular disease who carry anti-AChR or anti-MuSK antibodies, dosed twice a year after two loading doses. It is the first CD19 therapy in the indication, entering a market already crowded with newer biologics.

• FDA approves Uplizna for adults with generalised myasthenia gravis - Amgen

GSK’s outgoing chief said the US is still the best place to invest, warning the UK risks falling behind.

Speaking as she prepares to leave GSK at the year’s end, Emma Walmsley said the US remained the leading market in the world for launching new drugs and vaccines, reiterating that GSK will invest >$30bn into the US by 2030. She called improvement in the UK’s life-sciences commercial environment, “absolutely critical” to growth.

• UK still at risk of falling behind in life sciences, says Emma Walmsley - The Times

• GSK to invest $30bn in R&D and manufacturing in the US over next 5 years

ALETH · OPEN ACCESS RESEARCH

aleth.co

The Aleth Briefs trace each story to its original source and show how the week unfolded.

The week in five lines

• The US and UK struck a zero-tariff drug deal.

• Eli Lilly said the deal was not enough to unfreeze its UK investment.

• The FDA lost its (new) CDER chief Pazdur, appointing Hoeg as replacement.

• A German court blocked Merck‘s subcutaneous Keytruda.

• BMS delayed its Cobenfy Alzheimer’s readout.

In this edition

• Monday: US-UK drug deal; WHO obesity guideline; Belite Stargardt win; Regeneron-Tessera gene writing

• Tuesday: FDA Pazdur exit; Medline US IPO; FDA primate testing

• Wednesday: BMS Cobenfy delay; Capricor Duchenne win; Pharvaris HAE win; Medtronic Hugo robot; Lilly Jaypirca expansion

• Thursday: FDA Hoeg appointment; AstraZeneca-Neurimmune deal; Lilly UK freeze; Merck Keytruda blocked in Germany; US-WuXi scrutiny

• Friday: UK science ‘third-worldish’

Monday 1 December

The US and UK announced an (in principle) pharma deal, with the US offering tariff protection in exchange for higher UK prices for new medicines.

The agreement in principle keeps US import duties on UK pharma exports at zero for at least three years, which the government said was the lowest rate of any country. In return, the UK will increase the net price it pays for new medicines by 25% and cut the rebate rate drugmakers repay under the Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG) to a maximum of 15% in 2026, from 23%.

NICE separately confirmed it would lift its infamous cost-effectiveness threshold from a range of £20,000 to £30,000 up to a range of £25,000 to £35,000 per quality-adjusted life year (QALY) from April 2026, its first increase since 1999.

• Landmark UK-US pharmaceuticals deal to safeguard medicines access - GOV.UK

• US government announces agreement in principle with the United Kingdom on pharmaceutical pricing - Office of the United States Trade Representative

• Changes to NICE’s cost-effectiveness thresholds confirmed - NICE

The WHO issued its first guideline on GLP-1 obesity medicines.

The World Health Organization issued a conditional recommendation that GLP-1 drugs such as Wegovy and Mounjaro may be used for long-term treatment of obesity in adults, its first such guideline, while cautioning that fewer than one in ten eligible people will have access by 2030. It urged governments to widen access and pressed manufacturers to raise production and cut prices.

• WHO issues global guideline on use of GLP-1 medicines in treating obesity - WHO

• WHO says weight-loss drugs ‘new chapter’ in fight against obesity - The Guardian

Belite Bio’s tinlarebant succeeded in a phase 3 Stargardt disease trial.

In the phase 3 DRAGON trial in 104 adolescents and young adults, once-daily oral tinlarebant cut the growth rate of retinal atrophy lesions by 36% against placebo (p=0.0033). Stargardt, an inherited disease causing progressive sight loss from childhood, has no approved treatments. Belite plans to file with the FDA in H1 2026.

• New hope for people living with a disease once deemed untreatable - Belite Bio

Regeneron put $150m into Tessera Therapeutics’ gene-writing therapy for a genetic lung and liver disease.

The pair will jointly develop and commercialise TSRA-196, an in vivo gene-writing candidate for alpha-1 antitrypsin deficiency (AATD) that aims to correct the mutation at the SERPINA1 gene. Tessera takes $150m in upfront / equity, with up to $125m more in milestones, and the two will split worldwide costs and profits 50:50. This is one of the largest industrial bets yet on gene writing, which sits between gene editing and gene replacement and has no approved product.

• Regeneron and Tessera Therapeutics to jointly develop TSRA-196 - Regeneron

Tuesday 2 December

Rick Pazdur, the FDA’s top drug regulator, is leaving weeks after taking the job.

STAT reported that Pazdur, who took over CDER on 11 November after decades running FDA oncology reviews, filed to retire by month’s end. His exit followed a memo from CBER director Vinay Prasad and friction over Commissioner Marty Makary’s priority vouchers and hiring. By STAT’s account, he is CDER’s fourth director departure in 2025, a churn BIO called a weakness that rival China could exploit.

Richard Pazdur, FDA’s top cancer drug regulator, set to retire - STAT News

Medline prepared for a $5bn flotation, set to be the largest US listing of 2025.

Bloomberg reported that the medical-supplies group, taken private in 2021 by Blackstone, Carlyle and Hellman & Friedman, could begin marketing the IPO as soon as next week and was seeking $2bn from cornerstone funds before taking orders.

• Medline weighs marketing $5 billion IPO as soon as Monday - Bloomberg

The FDA moved to cut primate testing from antibody safety studies.

The agency published draft guidance identifying antibody types for which long non-human primate toxicity studies can be reduced or dropped in favour of a weight-of-evidence assessment. A typical antibody programme can use more than 100 primates at $50k in costs each. It is the latest step in the FDA’s move away from animal testing.

• FDA releases draft guidance reducing testing on NHPs for mAbs - FDA

Wednesday 3 December

BMS delayed the year-end readout of its Cobenfy trial in Alzheimer’s psychosis.

Bristol Myers Squibb identified “irregularities due to clinical trial execution at a small number of study sites“ in the phase 3 ADEPT-2 study and will exclude these from the primary analysis. After an FDA-agreed interim look, the data monitoring committee recommended the trial continue by enrolling more patients, pushing the readout to the end of 2026. Cobenfy is the schizophrenia drug BMS paid $14bn for Karuna to get, with Alzheimer’s psychosis the indication meant to take it beyond its first market.

• BMS announces continuation of ADEPT-2 phase 3 study in AD psychosis - BMS

Capricor’s deramiocel hit its primary endpoint in a phase 3 DMD trial.

HOPE-3 randomised 106 participants with Duchenne muscular dystrophy (DMD); in the primary PUL analysis of 105 evaluable patients, the cell therapy slowed loss of upper-limb function by 54% against placebo (p=0.029), with a supportive cardiac signal. The FDA rejected Capricor’s first application earlier in 2025.

• Capricor announces positive topline results from HOPE-3 phase 3 - Capricor

Pharvaris’s deucrictibant Phase 3 succeeded, challenging Ekterly

In the RAPIDe-3 trial, the oral drug brought relief from an acute attack in a median 1.28 hours against more than 12 hours on placebo (p<0.0001), with most attacks settled by a single capsule. Pharvaris plans to file with the FDA in H1 2026 for on-demand treatment, where KalVista’s Ekterly reached the market first.

• Pharvaris announces positive topline data from RAPIDe-3 pivotal study

Medtronic’s Hugo robot cleared FDA, its first US foothold against Intuitive

The clearance covers prostate, kidney and bladder procedures, about 230,000 US operations a year, on the strength of the Expand URO study. Hugo has been sold in more than 30 countries for years while Intuitive Surgical’s da Vinci has long held a near-monopoly on robotic surgery in the US.

Medtronic announces FDA clearance of Hugo robotic surgery system

Eli Lilly won an earlier-line FDA approval for Jaypirca in CLL.

The expansion allows Jaypirca (pirtobrutinib), the sole non-covalent BTK inhibitor, to treat relapsed or refractory CLL/SLL after a covalent BTK inhibitor, converting its December 2023 accelerated approval into a traditional one. In the Phase 3 BRUIN CLL-321 trial, Jaypirca cut progression or death risk by 42%, positioning it directly after covalent options like AZ’s Calquence or AbbVie’s Imbruvica.

US FDA approves expanded indication for Lilly’s Jaypirca - Eli Lilly

Thursday 4 December

The FDA named Tracy Beth Hoeg acting director of CDER

Reuters reported that Hoeg, who joined the FDA in April 2025 and helped lead a review of Covid vaccine safety, would take over the Center for Drug Evaluation and Research (CDER) after Rick Pazdur’s sudden departure. The centre that clears every new US medicine is now on its second interim leadership change in a month.

• FDA appoints Tracy Hoeg as acting director of drug evaluation center - Reuters

AstraZeneca partnered again with Neurimmune, committing up to $780m

AZ’s Alexion rare-disease unit will develop and commercialise NI009, a preclinical antibody targeting the light-chain fibrils that drive AL amyloidosis. Neurimmune will receive an undisclosed upfront payment, up to $780m in contingent milestones and tiered royalties. It follows a first, much smaller Neurimmune deal about four years ago.

• Neurimmune expands its collaboration with AstraZeneca to develop and commercialise NI009 for AL amyloidosis

Lilly said UK-US pricing deal not enough to unfreeze its paused UK investment.

Chief executive David Ricks told the FT that Lilly would wait to see how promises on medicine spending and faster approvals worked in practice before restarting the paused Lilly Gateway Labs incubator it halted earlier in 2025 over NHS pricing terms.

• Eli Lilly reconsiders UK biotech incubator, pauses buildout - FierceBiotech

A German court blocked Merck’s subcut Keytruda on Halozyme injunction.

A Munich court granted Halozyme a preliminary injunction barring Merck from distributing subcutaneous Keytruda in Germany over imminent patent infringement. The under-the-skin formulation key to Merck’s loss of exclusivity defence strategy for its infused version affects one of Europe’s largest markets.

Halozyme wins preliminary injunction against Merck’s Keytruda SC in Germany

Bloomberg: Pentagon pushed to add WuXi AppTec to Chinese military list.

Fierce Pharma reported that Bloomberg uncovered a 7 October letter in which Deputy Defense Secretary Stephen Feinberg urged Congress to add eight firms, including WuXi AppTec, to the Department of Defense’s Section 1260H list. WuXi survived last year’s Biosecure Act with its US business intact, but a listing puts those ties back under defense procurement review. Close to four in five US biopharma companies rely on Chinese firms for some part of their supply chain.

After dodging Biosecure threat, WuXi AppTec in Pentagon’s crosshairs - Fierce Pharma

Friday 5 December

Royal Society president UK research facilities “third worldish” next to China’s.

Sir Paul Nurse told The Times that British research infrastructure was looking “increasingly third-worldish“ beside China’s, and urged closer scientific ties with Beijing. He noted the UK invests only about 0.5% of GDP in science, leaving it low in the international tables, as China presses ahead with large-scale investment.

• UK research facilities look ‘increasingly third-worldish’ next to China’s - The Times

• New president speaks out on challenges to science - Royal Society

ALETH · OPEN ACCESS RESEARCH

aleth.co

The Aleth Briefs trace each story to its original source and show how the week unfolded.

The week in five lines

• Eli Lilly became the first $1tn drugmaker.

• Medicare set 2027 semaglutide prices 71% below 2024 list.

• Novo Nordisk‘s semaglutide failed in Alzheimer’s.

• The UK Budget widened venture and share-option reliefs.

• NICE‘s final draft backed Autolus‘s UK-invented CAR-T.

In this edition

• Monday: Lilly hits $1tn; AstraZeneca Maryland; FDA aide controversy; Novo Alzheimer’s miss; J&J tau miss; Bayer stroke win; FDA bladder approval; Kelun lung ADC; Agilent Q4

• Tuesday: US-UK pricing deal; NICE backs Autolus; Novartis SMA approval; Novo amycretin; Abbott sensor correction

• Wednesday: Medicare price cuts; Sanofi HQ searched; FDA companion diagnostics

• Thursday: UK Budget reliefs

• Friday: UK prostate screening

Monday 24 November

Eli Lilly became the first healthcare company worth $1 trillion

An achievement only tech firms and Berkshire Hathaway have reached before, Lilly crossed the line on Friday 21 November, up more than 37% on the year. The engine of growth has been its two tirzepatide brands, Mounjaro for diabetes and Zepbound for obesity. Mounjaro turned over $6.5bn in Q3 2025, up 109% YoY, and Zepbound $3.6bn, up 185%, taking the two from $4.4bn to $10.1bn YoY. Novo Nordisk, losing obesity share to Lilly through the year, was down 45% for 2025 on the same day.

• Eli Lilly hits $1 trillion market value, a first in health care - CNBC

• Lilly Q3 2025 results - Eli Lilly

AstraZeneca will put $2bn into Maryland.

AstraZeneca will nearly double capacity at its Frederick biologics plant and bring rare-disease manufacturing onshore for the first time. The money splits between the Frederick expansion and a new clinical manufacturing site in Gaithersburg for trial supply, both of which will be operational by 2029. Across both, AstraZeneca counts 2,600 jobs supported and 300 newly created. This is the fourth announcement of 2025 under the $50bn commitment AstraZeneca set out in July.

• AstraZeneca plans $2 billion manufacturing investment in Maryland, supporting 2,600 jobs and catalysing economic growth - AstraZeneca

FDA aide resignation demand withdrawn

An FDA official was told to resign before the demand was reversed, adding to signs of instability within the agency’s leadership.

• The White House has asked for the resignation of a top aide to FDA chief - POLITICO

Novo Nordisk’s semaglutide failed to slow Alzheimer’s in two phase 3 trials.

The evoke and evoke+ trials randomised 3,808 adults aged 55 to 85 with mild cognitive impairment or mild dementia and confirmed amyloid, to once-daily oral semaglutide 14 mg or placebo. Neither confirmed superiority on the primary endpoint, change in Clinical Dementia Rating - Sum of Boxes at week 104. Novo said treatment improved Alzheimer’s-related biomarkers but “this did not translate into a delay of disease progression,” and is discontinuing the one-year extension in both trials.

• Evoke phase 3 trials did not demonstrate a statistically significant reduction in Alzheimer’s disease progression - Novo Nordisk

J&J’s posdinemab misses in phase 2 Alzheimer’s trial

Posdinemab missed the primary endpoint. The Auτonomy trial randomised more than 500 adults to a high dose, a low dose or placebo, against a primary endpoint of change in the integrated Alzheimer’s Disease Rating Scale at week 104, and J&J is discontinuing the study.

• Johnson & Johnson statement on the Auτonomy study - Johnson & Johnson

• Auτonomy study record (NCT04619420) - ClinicalTrials.gov

Bayer’s oral Factor XIa inhibitor cut the risk of ischaemic stroke in phase 3.

In >12,300 patients after a non-cardioembolic ischaemic stroke or high-risk transient ischaemic attack, asundexian 50 mg once daily on top of antiplatelet therapy beat placebo on the primary endpoint of OCEANIC-STROKE, with no increase in ISTH major bleeding. Bayer called it the first successful phase 3 trial of a Factor XIa inhibitor and said it would engage health authorities in preparation for submissions. Bayer’s OCEANIC-AF trial in atrial fibrillation was stopped in 2023 for inferiority to apixaban.

• Bayer’s asundexian met primary efficacy and safety endpoints in landmark Phase III OCEANIC-STROKE study in secondary stroke prevention - Bayer

The FDA approved Padcev with Keytruda before and after surgery in muscle-invasive bladder cancer, five months ahead of its goal date.

The clearance covers enfortumab vedotin plus pembrolizumab as neoadjuvant then adjuvant treatment in adults ineligible for cisplatin. In KEYNOTE-905/EV-303, 344 previously untreated patients were randomised against surgery alone: median event-free survival was not reached against 15.7 months, a hazard ratio of 0.40, and median overall survival was not reached against 41.7 months, a hazard ratio of 0.50. Grade 3 or worse adverse events ran at 71.3% against 45.9%.

• FDA approves pembrolizumab with enfortumab vedotin-ejfv for muscle invasive bladder cancer - FDA

• U.S. FDA approves Padcev plus Keytruda for certain patients with muscle invasive bladder cancer - Pfizer/Astellas

Merck & Co’s partner Kelun-Biotech reported a phase 3 win for the TROP2 antibody-drug conjugate sac-TMT with Keytruda in first-line lung cancer.

In OptiTROP-Lung05, sacituzumab tirumotecan plus pembrolizumab beat pembrolizumab alone on progression-free survival at a pre-specified interim analysis, in PD-L1-positive advanced non-small cell lung cancer (NSCLC) with a tumour proportion score of 1% or more. Overall survival showed a positive trend. Kelun plans to discuss a supplemental filing with China’s regulator. Merck & Co (MSD) holds rights outside Greater China and is running 15 global phase 3 studies of the drug.

• Kelun-Biotech announces Phase III trial of sac-TMT in combination with Keytruda as first-line treatment for PD-L1-positive NSCLC met primary endpoint - Kelun-Biotech

Agilent Q4 revenue of $1.9bn, up 9.4%, driven by life sciences and diagnostics.

Fiscal Q4 revenue was $1.86bn, up 9.4%, with the Life Sciences and Diagnostics Markets Group up 15% to $755m. FY2025 revenue of $6.95bn came in above guidance, and the FY2026 guide of $7.3-7.4bn implies growth of about 5 to 6.5%.

• Agilent reports fourth-quarter fiscal year 2025 financial results - Agilent Technologies

Tuesday 25 November

The US and UK were reported to be near a possible agreement linking UK medicine spending and pricing to relief from US pharma tariffs.

Endpoints News, citing two UK-based sources, said the agreement could be finalised in the week of 24 November, with the UK paying more for some medicines in return for relief from pharmaceutical tariffs and a cut to the rebate rate drugmakers pay under the Voluntary Scheme for Branded Medicines Pricing, Access and Growth (VPAG). Neither government published anything on it by the end of the week, and the Budget on 26 November made no mention of VPAG or branded medicines pricing.

• UK-US drug pricing deal could come as early as this week, sources say - Endpoints News (reported deal terms)

NICE backed Autolus’s CAR-T therapy obe-cel for NHS use in adults 26 and over.

The final draft guidance covers obe-cel (Aucatzyl) in relapsed or refractory B-cell precursor acute lymphoblastic leukaemia, with NICE putting the eligible group at around 150 people over three years. NICE’s final draft guidance recommended routine commissioning rather than the Cancer Drugs Fund, subject to appeal and final guidance. List price is £372,000 per infusion, with a confidential discount to the NHS. The CD19 CAR-T came from a team led by Martin Pule at UCL.

• NICE recommends Aucatzyl (obe-cel) as a treatment option for adult patients (≥26 years) with relapsed or refractory B-cell precursor ALL - Autolus Therapeutics

• Obecabtagene autoleucel: final draft guidance - NICE

The FDA approved Itvisma, an intrathecal version of Novartis’s Zolgensma.

Itvisma puts the same gene into the cerebrospinal fluid (CSF) rather than the bloodstream, as a one-time fixed dose that does not need to be adjusted for age or body weight, compared with IV Zolgensma, which is weight-based and approved only for children <2 yrs. Approval follows the phase 3 STEER trial, where motor function improved against sham over 52 weeks, supported by the open-label STRENGTH study. Novartis put the price at $2.59m, against $2.1m for intravenous Zolgensma.

• Novartis receives FDA approval for Itvisma, the only gene replacement therapy for children two years and older, teens, and adults with SMA - Novartis

• Novartis scores FDA approval for new version of SMA gene therapy, prices at $2.59M - Fierce Pharma

Novo Nordisk’s amycretin cut weight by up to 14.5% in a phase 2 diabetes trial.

The 448-patient study tested the amylin and GLP-1 receptor co-agonist in type 2 diabetes inadequately controlled on metformin, over up to 36 weeks. On an on-treatment basis, the once-weekly injection reduced weight by up to 14.5% against 2.6% on placebo and cut HbA1c by up to 1.8 points, with 89.1% of patients getting below 7%. Novo now plans a phase 3 in type 2 diabetes in 2026.

• Novo Nordisk phase 2 trial with amycretin reports significant weight loss and HbA1c reduction in type 2 diabetes - Novo Nordisk

Abbott is replacing about 3 million FreeStyle Libre 3 glucose sensors in the US after a manufacturing fault made some read glucose too low.

The correction covers Libre 3 and Libre 3 Plus sensors from a single production line. Abbott warned that undetected low readings over an extended period may lead to incorrect treatment decisions. It reported 736 severe adverse events and seven deaths globally as potentially associated, of which 57 severe events and no deaths were in the US. Abbott says it has found and fixed the manufacturing cause.

• Abbott initiates medical device correction for certain FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the U.S. - Abbott

Wednesday 26 November

Medicare set 2027 prices for Novo’s semaglutide products 71% below 2024 list.

The negotiated maximum fair price, effective 1 January 2027, is $274 for a standardised 30-day supply across Ozempic, Rybelsus and Wegovy, against a $959 2024 list-price benchmark. CMS’s 15 negotiated prices are 38%–85% below 2024 list prices. CMS put the saving at $12bn on 2024 volumes, or $8.5bn once Coverage Gap Discount Program spending is counted. Ozempic, Rybelsus and Wegovy are the largest line item at $15.2bn of Part D gross costs across 2.3m enrollees.

• CMS delivers savings for seniors on 15 major drugs for cancer and chronic disease - Centers for Medicare & Medicaid Services (CMS)

• Fact sheet: Medicare Drug Price negotiated prices for 2027 - CMS

Thirty investigators searched Sanofi’s Paris HQ in an inquiry into laundering the proceeds of tax fraud.

Le Monde broke the story and had it confirmed by the Parquet National Financier (PNF). The preliminary investigation, open since January 2024, also names Lactalis and AXA, and turns on tax-driven financing structures a Societe Generale unit built for large French companies. Sanofi said it considers it complied with all applicable law, reserves its rights and will cooperate.

• Soupçons de blanchiment de fraude fiscale : le siège de Sanofi perquisitionné - Le Monde

The FDA proposed moving molecular companion diagnostics out of its highest-risk class, cutting them from premarket approval to the 510(k) route.

The proposed order creates a device type at 21 CFR 866.6075 for nucleic acid-based test systems used with an approved oncology therapeutic, covering four product codes across real-time PCR, sequencing, next-generation sequencing and melt-curve analysis. The scope stops at molecular oncology tests. Protein and immunohistochemistry companion diagnostics are untouched.

• Immunology and microbiology devices; reclassification of nucleic acid-based test systems for use with a corresponding approved oncology therapeutic product - FDA

Thursday 27 November

The UK Autumn Budget doubled VCT limits and widened EMI share options.

From April 2026 the annual VCT and EIS investment limit goes to £10m, or £20m for knowledge-intensive companies, with lifetime limits of £24m and £40m and the gross assets test up to £30m before a share issue. VCT income tax relief drops from 30% to 20%. Enterprise Management Incentive schemes move to a 500-employee limit, a £120m gross assets test, a £6m option pool and a 15-year holding period, with the notification requirement (a procedural trap for companies) gone from April 2027.

• Budget 2025: Strong foundations, secure future - HM Treasury

Friday 28 November

UK screening advisers back targeted PSA testing for men with BRCA variants

The UK National Screening Committee proposed regular PSA testing for men with a confirmed BRCA1 or BRCA2 variant, while recommending against a national population-wide prostate cancer screening programme. The committee cited false positives and negatives from PSA tests, the difficulty of separating indolent from aggressive cancers, and the serious impacts of overtreatment. The proposal followed a letter from more than 120 MPs, led by Rishi Sunak, pressing for targeted screening.

• UK NSC opens consultation on draft prostate cancer screening recommendation - UK National Screening Committee

• >120 MPs warn ‘frozen’ diagnosis system is costing lives - Prostate Cancer Research

ALETH · OPEN ACCESS RESEARCH

aleth.co

The Aleth Briefs trace each story to its original source and show how the week unfolded.

The week in five lines

• Abbott bought Exact Sciences for $23bn.

• The FDA restricted Sarepta’s Elevidys after two deaths.

• The CDC called the no-autism-link claim not evidence-based.

• A US court confirmed Purdue Pharma’s $7.4bn opioid settlement.

• MPs warned life sciences sector has lost confidence in UK government.

In this edition

• Monday: Purdue settlement; FDA limits Elevidys; Jazz gastric cancer; J&J Halda

• Tuesday: Roche breast cancer Ph3

• Wednesday: Alkermes-Avadel bid; US-China API risk

• Thursday: Abbott buys Exact; US CDC autism; UK lost confidence

• Friday: GE HealthCare-Intelerad; Merck KGaA AI deal

Monday 17 November

A US bankruptcy court confirmed Purdue Pharma’s opioid settlement

The US Bankruptcy Court for the Southern District of New York confirmed Purdue’s Chapter 11 plan, ending six years of proceedings and replacing an earlier settlement the US Supreme Court struck down in 2024. This clears $7.4bn to claimants, of which the Sackler family will fund $6.5bn. Purdue is dissolved and its business passes to Knoa Pharma, a public benefit company owned by a non-profit foundation, with a court injunction barring it from marketing opioids and lobbying.

Sources:

• Bankruptcy Court to Confirm Purdue Pharma’s Plan of Reorganization - Purdue Pharma

The FDA restricted Sarepta’s Duchenne gene therapy Elevidys after two teenage deaths from liver failure

The agency approved updated labelling limiting Elevidys (delandistrogene moxeparvovec) to ambulatory patients 4 and older with a confirmed dystrophin-gene mutation, removing the prior indication for those who can no longer walk. The boxed warning covers serious liver injury, acute liver failure and death. The action follows two fatal cases of acute liver failure in non-ambulatory teenage boys, flagged in June.

Sources:

• FDA approves new safety warning and revised indication that limits use for Elevidys following reports of fatal liver injury - FDA

Jazz Pharmaceuticals reported a first-line win for its HER2 drug Ziihera in advanced stomach and oesophageal cancer.

In the Phase 3 HERIZON-GEA-01 trial, Ziihera (zanidatamab), a HER2-targeted bispecific antibody, plus chemotherapy with or without the PD-1 inhibitor tislelizumab, significantly improved progression-free survival against trastuzumab plus chemotherapy in first-line HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma. The regimen adding tislelizumab also significantly improved overall survival. Jazz plans a supplemental US filing in H1 2026.

Sources:

• Positive HERIZON-GEA-01 Phase 3 results support Ziihera in first-line HER2-positive gastroesophageal adenocarcinoma - Jazz Pharmaceuticals

J&J agreed to buy Halda Therapeutics for $3bn, adding an early-stage prostate-cancer drug built on a “hold and kill” mechanism.

The all-cash deal brings J&J the private company’s RIPTAC platform, which makes oral bifunctional small molecules that tether a tumour-survival protein to a target protein to kill cancer cells selectively. The lead candidate, HLD-0915, is a once-daily treatment for metastatic castration-resistant prostate cancer in early trials, with further programmes in breast, lung and other solid tumours.

Sources:

• Johnson & Johnson set to revolutionize the treatment of cancer with the acquisition of Halda Therapeutics - Johnson & Johnson

Tuesday 18 November

Roche’s oral breast-cancer pill giredestrant became the first of its class to improve outcomes in early-stage disease, its second straight Phase 3 win.

In an interim analysis of the Phase 3 lidERA trial, adjuvant giredestrant, an oral selective estrogen receptor degrader (SERD), significantly improved invasive disease-free survival against standard therapy in oestrogen-receptor-positive, HER2-negative early breast cancer. The trial enrolled >4,100 patients with medium- or high-risk stage I-III disease. Roche said it is the first oral SERD to show that benefit in the adjuvant setting, following the drug’s earlier win in metastatic disease at ESMO 2025.

Sources:

• Roche’s giredestrant becomes the first oral SERD to show superior invasive disease-free survival in early breast cancer - Roche

Wednesday 19 November

Alkermes raised its offer for Avadel to $22.50 a share, seeing off a surprise counterbid from Denmark’s Lundbeck.

Alkermes lifted its bid to $21.00 in cash plus a contingent value right (CVR) worth up to $1.50, tied to US approval of Avadel’s narcolepsy drug Lumryz in idiopathic hypersomnia by the end of 2028, valuing Avadel at up to about $2.4bn. The raise answered an unsolicited Lundbeck proposal of up to $23.00 a share that Avadel’s board had judged likely superior, though it viewed the Lundbeck milestone as unlikely to pay out. Both boards approved the amended terms. Completion: Q1 2026.

Sources:

• Alkermes plc announces increased offer to acquire Avadel Pharmaceuticals plc - Alkermes

A US congressional commission warned that American dependence on China for the building blocks of medicines is a national-security risk.

The US-China Economic and Security Review Commission released its 2025 annual report to Congress, with a chapter arguing that heavy reliance on China for active pharmaceutical ingredients (APIs) and key starting materials leaves US drug supply exposed. It recommended Congress require transparency on where ingredients are sourced and fund efforts to reduce dependence, including domestic production. The findings feed the tariff and reshoring debate now shaping pharma investment.

Sources:

• 2025 report to Congress of the U.S.-China Economic and Security Review Commission - U.S.-China Economic and Security Review Commission

Thursday 20 November

Abbott agreed to buy Exact Sciences for about $23bn, its largest acquisition in nearly a decade and the biggest cancer-diagnostics deal on record.

The cash deal at $105.00 a share is an enterprise value of c.$23bn including net debt. It brings Abbott the Cologuard colorectal screening test, the Oncotype DX genomic test and the Oncodetect molecular residual disease (MRD) test, plus blood-based multi-cancer early-detection (MCED) programmes. Exact Sciences is expected to add >$3bn in revenues, taking Abbott diagnostics sales to >$12bn a year. Abbott expects to close in Q2 2026 and plans to push Exact’s products into international markets.

Sources:

• Abbott to acquire Exact Sciences, a leader in cancer screening and precision oncology diagnostics - Abbott

The US CDC rewrote its vaccine-safety page to call the statement that vaccines do not cause autism “not evidence-based”.

The revised text, which appeared under Health Secretary Robert F. Kennedy Jr., keeps the header “Vaccines do not cause autism” but adds that the claim “is not an evidence-based claim because studies have not ruled out the possibility that infant vaccines cause autism.” The wording contradicts a large body of research finding no such link. Public-health bodies and researchers condemned the change, part of a run of shifts in US vaccine policy.

Sources:

• Vaccine safety: vaccines and autism - CDC

A Commons committee chair told the government the life sciences sector had “lost confidence” in it, and pressed for answers before the Budget.

In a letter to Health Secretary Wes Streeting, Dame Chi Onwurah, chair of the Science, Innovation and Technology Committee, said the sector had “lost confidence in the credibility of successive UK governments to deliver” on the pricing and uptake of new medicines, and called NICE’s processes “needlessly complex.” She asked how US trade talks were bearing on domestic pricing negotiations and what the government would do for the sector in the Budget.

Sources:

• Government must make urgent changes to restore confidence of UK life sciences sector, Committee warns - House of Commons Science, Innovation and Technology Committee

Friday 21 November

GE HealthCare agreed to buy medical-imaging software firm Intelerad for about $2.3bn to widen its cloud diagnostics business.

The all-cash deal buys Intelerad from private-equity owner Hg. Its cloud-based radiology and cardiology software reaches into outpatient, teleradiology and hospital settings, extending GE HealthCare beyond its in-hospital imaging base. The company said the purchase would help it triple its cloud-enabled products by 2028 and layer AI on top, with completion expected in H1 2026.

Sources:

• GE HealthCare to acquire Intelerad, advancing cloud-enabled enterprise imaging across care settings - GE HealthCare

Germany’s Merck KGaA signed an AI drug-discovery pact with Valo Health worth >$3bn to target Parkinson’s disease.

Announced on 20 November, the deal applies Valo’s AI platform, built on >17 million patient records and biobank samples, to find and validate drug targets and generate preclinical compounds for Parkinson’s and related disorders. Merck KGaA will pay an undisclosed upfront sum with milestones taking the total past $3bn, plus royalties and research funding. It is the German group’s second neurology collaboration this year.

Sources:

• Valo Health announces collaboration with Merck KGaA, Darmstadt, Germany for Parkinson’s disease - Valo Health

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